UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE
ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of November 2023
Commission File Number: 001-40552
NYXOAH SA
(Translation of registrant’s name into English)
Rue Edouard Belin 12,
1435 Mont-Saint-Guibert, Belgium
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form 20-F
x Form 40-F ¨
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Note:
Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached
annual report to security holders.
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
Note:
Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other
document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant
is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home
country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release,
is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has
already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Nyxoah SA
On November 8, 2023, Nyxoah SA (the “Company”)
issued a press release announcing its financial and operating results for the third quarter of 2023. A copy of the Company’s press
release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Additionally, on November 8, 2023, the Company
announced its unaudited third quarter results for 2023, which are further described in a Third Quarter 2023 report attached hereto as
Exhibit 99.2.
The information in the attached Exhibit 99.1
is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of
1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated
by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise
set forth herein or as shall be expressly set forth by specific reference in such a filing.
The
information in the attached Exhibit 99.2 shall be deemed to be incorporated by reference into the registration statements on Form S-8
(Registration Numbers 333-261233 and 333-269410) and Form F-3 (Registration Number 333-268955) of the Company (including any prospectuses forming a part of such registration statements) and to be a part thereof
from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibits
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
NYXOAH
SA |
|
|
|
Date:
November 8, 2023 |
By: |
/s/
Loic Moreau |
|
Name: |
Loic
Moreau |
|
Title: |
Chief
Financial Officer |
Exhibit 99.1
REGULATED
INFORMATION
Nyxoah
Reports Third Quarter 2023 Financial and Operating Results
Partners
with ResMed Germany to increase OSA awareness and therapy penetration
Mont-Saint-Guibert,
Belgium – November 8, 2023 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah”
or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions
to treat Obstructive Sleep Apnea (OSA), today reported financial and operating results for the third quarter of 2023.
Recent
Financial and Operating Highlights
| · | Filed
the third module in the modular PMA submission. |
| · | Accelerated
U.S. pre-commercialization efforts, focused on market access around CPT coding. |
| · | Initiated
a commercial partnership with strategic investor ResMed in Germany. This collaboration introduces
a novel continuum of care into the German OSA market. |
| · | Reported
third-quarter sales of €1.0 million and ended the quarter with 46 active German accounts. |
| · | Ended
the quarter with a cash position of €72.5 million, providing an anticipated cash runway
into late 2024. |
“Nyxoah
is entering one of the most exciting times in the company’s history. We will report data from our DREAM U.S. pivotal trial early
next year, shortly thereafter complete our modular PMA submission, and expect FDA approval late 2024,” commented Olivier Taelman,
Chief Executive Officer. “Hypoglossal nerve stimulation (HGNS) remains highly underpenetrated and guiding patients through their
OSA journey is key to unlocking the market’s potential. Our agreement with ResMed Germany, which takes ResMed from a valued investor
to commercial partner, creates a continuum of care that directs patients towards the appropriate treatment, resulting in greater therapy
penetration.”
REGULATED
INFORMATION
CONSOLIDATED
STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)
(in
thousands)
| |
For
the three months
ended September 30 | | |
For
the nine months
ended September 30 | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenue | |
€ | 976 | | |
€ | 182 | | |
€ | 2,524 | | |
€ | 1,777 | |
Cost of
goods sold | |
| (336 | ) | |
| (63 | ) | |
| (930 | ) | |
| (685 | ) |
Gross profit | |
€ | 640 | | |
€ | 119 | | |
€ | 1,594 | | |
€ | 1,092 | |
Research and Development Expense | |
| (6,568 | ) | |
| (4,221 | ) | |
| (19,330 | ) | |
| (11,286 | ) |
Selling, General and Administrative
Expense | |
| (5,058 | ) | |
| (4,763 | ) | |
| (16,794 | ) | |
| (13,492 | ) |
Other income/(expense) | |
| – | | |
| 87 | | |
| 265 | | |
| 237 | |
Operating loss for the
period | |
€ | (10,986 | ) | |
€ | (8,778 | ) | |
€ | (34,265 | ) | |
€ | (23,449 | ) |
Financial income | |
| 2,178 | | |
| 5,127 | | |
| 3,592 | | |
| 11,372 | |
Financial
expense | |
| (1,033 | ) | |
| (2,524 | ) | |
| (2
765) | | |
| (5,473 | ) |
Loss for the period before
taxes | |
€ | (9,841 | ) | |
€ | (6,175 | ) | |
€ | (33,438 | ) | |
€ | (17,550 | ) |
Income
taxes | |
| 2,229 | | |
| (65 | ) | |
| 1,119 | | |
| (379 | ) |
Loss for the period | |
€ | (7,612 | ) | |
€ | (6,240 | ) | |
€ | (32,319 | ) | |
€ | (17,929 | ) |
| |
| | | |
| | | |
| | | |
| | |
Loss attributable to equity
holders | |
€ | (7,612 | ) | |
€ | (6,240 | ) | |
€ | (32,319 | ) | |
€ | (17,929 | ) |
Other comprehensive loss | |
| | | |
| | | |
| | | |
| | |
Items that may be subsequently
reclassified to profit or loss (net of tax) | |
| | | |
| | | |
| | | |
| | |
Currency
translation differences | |
| (10 | ) | |
| 100 | | |
| (88 | ) | |
| (14 | ) |
Total
comprehensive loss for the year, net of tax | |
€ | (7,622 | ) | |
€ | (6,140 | ) | |
€ | (32,407 | ) | |
€ | (17,943 | ) |
Loss
attributable to equity holders | |
€ | (7,622 | ) | |
€ | (6,140 | ) | |
€ | (32,407 | ) | |
€ | (17,943 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic Loss Per Share (in EUR) | |
€ | (0.266 | ) | |
€ | (0.242 | ) | |
€ | (1.166 | ) | |
€ | (0.695 | ) |
Diluted Loss Per Share (in EUR) | |
€ | (0.266 | ) | |
€ | (0.242 | ) | |
€ | (1.166 | ) | |
€ | (0.695 | ) |
REGULATED
INFORMATION
CONSOLIDATED
STATEMENT OF FINANCIAL POSITION (unaudited)
(in thousands)
| |
As
at | |
| |
September 30
2023 | | |
December 31
2022 | |
ASSETS | |
| | | |
| | |
Non-current assets | |
| | | |
| | |
Property, plant
and equipment | |
| 4,328 | | |
| 2,460 | |
Intangible assets | |
| 45,720 | | |
| 39,972 | |
Right of use assets | |
| 3,602 | | |
| 3,159 | |
Deferred tax asset | |
| 47 | | |
| 47 | |
Other long-term
receivables | |
| 668 | | |
| 173 | |
| |
€ | 54,365 | | |
€ | 45,811 | |
Current assets | |
| | | |
| | |
Inventory | |
| 1,709 | | |
| 882 | |
Trade receivables | |
| 1,918 | | |
| 1,463 | |
Other receivables | |
| 2,437 | | |
| 1,775 | |
Other current assets | |
| 1,683 | | |
| 1,284 | |
Financial assets | |
| 59,239 | | |
| 76,968 | |
Cash and
cash equivalents | |
| 13,250 | | |
| 17,888 | |
| |
€ | 80,236 | | |
€ | 100,260 | |
Total
assets | |
€ | 134,601 | | |
€ | 146,071 | |
| |
| | | |
| | |
EQUITY AND LIABILITIES | |
| | | |
| | |
Capital and reserves | |
| | | |
| | |
Capital | |
| 4,926 | | |
| 4,440 | |
Share premium | |
| 246,130 | | |
| 228,275 | |
Share based payment reserve | |
| 7,468 | | |
| 5,645 | |
Other comprehensive income | |
| 88 | | |
| 176 | |
Retained
loss | |
| (150,070 | ) | |
| (118,212 | ) |
Total
equity attributable to shareholders | |
€ | 108,542 | | |
€ | 120,324 | |
| |
| | | |
| | |
LIABILITIES | |
| | | |
| | |
Non-current liabilities | |
| | | |
| | |
Financial debt | |
| 8,407 | | |
| 8,189 | |
Lease liability | |
| 2,990 | | |
| 2,586 | |
Pension liability | |
| 75 | | |
| – | |
Provisions | |
| 125 | | |
| 59 | |
Deferred
tax liability | |
| 6 | | |
| – | |
| |
€ | 11,603 | | |
€ | 10,834 | |
Current liabilities | |
| | | |
| | |
Financial debt | |
| 769 | | |
| 388 | |
Lease liability | |
| 788 | | |
| 719 | |
Trade payables | |
| 4,480 | | |
| 4,985 | |
Current tax liability | |
| 2,367 | | |
| 3,654 | |
Other payables | |
| 6,052 | | |
| 5,167 | |
| |
€ | 14,456 | | |
€ | 14,913 | |
Total
liabilities | |
€ | 26,059 | | |
€ | 25,747 | |
Total
equity and liabilities | |
€ | 134,601 | | |
€ | 146,071 | |
REGULATED
INFORMATION
Revenue
Revenue
was €1.0 million for the third quarter ending September 30, 2023, compared to €182,000 for third quarter ending September 30,
2022.
Cost
of Goods Sold
Cost
of goods sold was €336,000 for the three months ending September 30, 2023, representing a gross profit of €640,000, or
gross margin of 66.0%. This compares to total cost of goods sold of €63,000 in the third quarter ending September 30, 2022, for
a gross profit of €119,000, or gross margin of 65.4%.
Research
and Development Expenses
Research
and development expenses were €6.6 million for the three months ending September 30, 2023, versus €4.2 million for the
prior year period, driven by an acceleration in clinical activities, notably the start of the ACCCESS study.
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses rose to €5.1 million for the third quarter of 2023, up from €4.8 million in the third quarter
of 2022. This was due primarily to increased commercial efforts in Germany and other European markets, as well as investments in Nyxoah’s
corporate infrastructure. The Company expects to continue adding headcount across the organization ahead of the U.S. commercial launch.
Operating
Loss
Total
operating loss for the third quarter 2023 was €11.0 million versus €8.8 million in the third quarter of 2022. This was driven
by the acceleration in the Company’s R&D spending, as well as ongoing commercial and clinical activities.
REGULATED
INFORMATION
Cash
Position
As
of September 30, 2023, cash and financial assets totaled €72.5 million, compared to €94.9 million on December 31, 2022.
Total cash burn was approximately €4.0 million per month during the third quarter of 2023.
Third
Quarter 2023 Report
Nyxoah’s
financial report for the third quarter 2023, including details of the consolidated results, are available on the investor page of
Nyxoah’s website (https://investors.nyxoah.com/financials).
Conference
call and webcast presentation
Nyxoah
will conduct a conference call open to the public today at 10:30pm CET / 4:30pm ET. A webcast of the call will be accessible via the
Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q3 2023 earnings call webcast. For those not
planning to ask a question of management, the Company recommends listening via the webcast.
If
you plan to ask a question, please use the following link: Nyxoah’s Q3 2023 earnings call. After registering, an email will
be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected
prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call.
The
archived webcast will be available for replay shortly after the close of the call.
About
Nyxoah
Nyxoah
is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea
(OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation
therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk
and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live
their life to its fullest.
Following
the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful
IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study,
Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently
contraindicated in competitors’ therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA
and U.S. commercialization approval.
For
more information, please visit http://www.nyxoah.com/.
REGULATED INFORMATION
Caution
– CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in
the United States.
Forward-looking
statements
Certain
statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company
directors' or managements' current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio®
system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and
potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system;
and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature,
forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or
events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions
and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks
and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of
the Company’s Annual Report on Form 20-F for the year ended December 31, 2022, filed with the Securities and Exchange
Commission (“SEC”) on March 22, 2023, and subsequent reports that the Company files with the SEC. A multitude of factors
including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ
significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities
are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in
the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this
press release, those results or developments may not be indicative of results or developments in future periods. No representations and
warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any
obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of
any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements
are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor
any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking
statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained
in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking
statements, which speak only as of the date of this press release.
Contacts:
Nyxoah
David
DeMartino, Chief Strategy Officer
david.demartino@nyxoah.com
+1
310 310 1313
Exhibit 99.2
Interim
financial report
ThIRD
QUARTER 2023
Table
of contents
Table of contents |
1 |
|
|
|
Interim financial
report |
3 |
|
|
|
THIRD QUARTER 2023 |
3 |
|
|
|
1. |
Business
update |
3 |
|
|
|
2. |
FINANCIAL HIGHLIGHTS |
4 |
|
|
|
3. |
2023 OUTLOOK |
5 |
|
|
|
4. |
RISK FACTORS |
5 |
|
|
|
5. |
FORWARD-LOOKING STATEMENTS |
5 |
|
|
|
Unaudited condensed
consolidated interim financial information as at and for the nine months ended September 30, 2023 – Interim consolidated
statement of financial position |
6 |
|
|
|
Unaudited condensed
consolidated interim financial information as at and for the nine months ended September 30, 2023 - Interim consolidated statements
of loss and other comprehensive loss |
7 |
|
|
|
Unaudited condensed
consolidated interim financial information as at and for the nine months ended, September 30 2023 - Interim consolidated statements
of changes in equity |
8 |
|
|
|
Unaudited condensed
consolidated interim financial information as at and for the nine months ended September 30, 2023 – Interim consolidated
statements of cash flows |
9 |
|
|
|
Notes to the unaudited
condensed interim consolidated financial information |
10 |
|
|
|
1. |
General information |
10 |
|
|
|
2. |
Significant accounting policies |
10 |
|
|
|
3. |
Critical accounting estimates
and assumptions |
11 |
|
|
|
4. |
Segment reporting |
11 |
|
|
|
5. |
Fair Value |
11 |
|
|
|
6. |
Subsidiaries |
12 |
|
|
|
7. |
Property, Plant and Equipment |
12 |
|
|
|
8. |
Intangible assets |
13 |
|
|
|
9. |
Right of use assets and lease
liabilities |
13 |
|
|
|
10. |
Other long-term receivables |
13 |
|
|
|
11. |
Inventory |
14 |
|
|
|
12. |
Trade and Other receivables |
14 |
|
|
|
13. |
Other current assets |
14 |
|
|
|
14. |
Cash and cash equivalents |
15 |
|
|
|
15. |
Financial assets |
15 |
|
|
|
16. |
Capital, Share Premium, Reserves |
15 |
|
|
|
17. |
Share-Based compensation |
17 |
|
|
|
18. |
Financial Debt |
19 |
|
|
|
19. |
Trade payables |
21 |
|
|
|
20. |
Income taxes and deferred taxes |
21 |
|
|
|
21. |
Other payables |
21 |
22. |
Derivatives |
22 |
|
|
|
23. |
Results of operation |
23 |
|
|
|
24. |
Employee benefits |
26 |
|
|
|
25. |
Financial income |
26 |
|
|
|
26. |
Financial expense |
27 |
|
|
|
27. |
Loss Per Share (EPS) |
27 |
|
|
|
28. |
Other commitments |
28 |
|
|
|
29. |
Related Party Transactions |
28 |
|
|
|
30. |
Events after the Balance-Sheet
Date |
30 |
|
|
|
Responsibility statement |
31 |
Interim
financial report
ThIRD
QUARTER 2023
DREAM US: IDE PIVOTAL STUDY
Nyxoah initiated its pivotal DREAM IDE trial
in the United States in December 2020 to support an application seeking FDA marketing authorization and, ultimately, reimbursement
in the U.S. for bilateral hypoglossal nerve stimulation for the treatment of moderate-to-severe obstructive sleep apnea (“OSA”).
The DREAM trial is a multicenter, prospective, open-label trial in which patients who undergo implantation of the Genio®
system will be followed for five years post-implantation to assess the safety and efficacy of the Genio® system in patients
with moderate-to-severe OSA.
The trial was initially expected to enroll 134
patients who will undergo the implantation procedure with 12-month effectiveness and safety primary endpoints across 18 centers in the
United States and six international sites. In April 2022, the FDA approved the Company’s request to reduce the trial’s
sample size to 115 patients from 134 after reviewing data from the BETTER SLEEP trial (see below).
The primary safety endpoint is incidence of device-related
severe adverse events ("SAEs") at 12-months post implantation. The co-primary effectiveness endpoints are the percentage of
responders with at least a 50% reduction on the apnea-hypopnea index ("AHI") with hypopneas associated with a 4% oxyhemoglobin
desaturation and a remaining AHI with hypopneas associated with a 4% oxyhemoglobin desaturation less than 20, and a 25% reduction on
the oxygen desaturation index ("ODI") between baseline and 12-month visits. Patients with moderate to severe OSA (AHI score
between 15 and 65) and aged between 22 and 75 years are eligible for enrolment if they failed, did not tolerate or refused positive airway
pressure ("PAP") treatment. Patients with a body mass index above 32 kg/m2, a complete concentric collapse ("CCC")
observed during a drug induced sleep endoscopy and combined central and mixed AHI above 25% at baseline polysomnography are to be excluded.
Enrollment in the DREAM trial is now complete,
and 115 patients have undergone a Genio® implantation procedure. The company presented 12-month efficacy data on the first 34 DREAM
patients and safety data, as of March 14, 2023, on all DREAM patients demonstrating a 65% AHI responder rate, a 76% ODI responder
rate and safety in-line with expectations. These data are preliminary and not conclusive of final DREAM success. For the trial to be
successful, of the 115 patients, at least 63% of patients need to be AHI and ODI responders at the 12-month follow-up. The Company anticipates
having 12-month clinical data in the first half of 2024 and, as of the date of this report, has submitted the first three modules in the modular PMA.
BETTER SLEEP: ACHIEVED PRIMARY ENDPOINT IN
BOTH CCC AND NON-CCC PATIENT COHORTS
In March 2022, the Company attended the
World Sleep Congress in Rome, Italy, and presented data generated from its BETTER SLEEP trial, a multicenter, prospective, open-label,
two-group clinical trial, designed to assess the long-term safety and performance of the Genio® system for the treatment of adult
OSA patients with and without CCC of the soft palate over a period of 36 months post-implantation. The BETTER SLEEP trial included a
subgroup of CCC patients, which is a patient population that is contraindicated for unilateral hypoglossal nerve stimulation.
In the BETTER SLEEP trial, 42 patients were implanted
with the Genio® system, 18 of whom presented with CCC (or 42.9% of the total implanted population) at eight research centers in Australia.
The primary safety endpoint was the incidence of device-related SAEs six months post-implantation. The primary performance endpoint was
achieving at least a 4-point reduction in the apnea-hypopnea index (4% oxygen desaturation, or AHI4) from baseline at six months for
the entire patient cohort. Patients with moderate to severe AHI scores (15 < AHI < 65) and aged between 21 and 75 years were eligible
for enrollment if they failed, refused or did not tolerate PAP treatment. Patients with a body mass index above 32 kg/m2 were excluded.
Three patients in the non-CCC arm and three patients
in the CCC arm did not complete their six-month polysomnography, and as a result, the analysis was calculated based on 36 patients (21
non-CCC and 15 CCC). Of these 36 patients, there were 23 responders (64%), including nine of the 15 CCC patients (60%) and 14 of the
21 non-CCC patients (67%), at six months. The overall reduction was statistically significant with an 11-point reduction (p<0.001),
with statistically significant reductions of 10 points (p=0.001) in the CCC cohort and 11 points (p<0.001) in the non-CCC cohort.
In addition, mean AHI4 reduction exceeded 70% among responders in both CCC and non-CCC cohorts. These results are subject to final review
and validation.
With respect to the primary safety endpoint,
preliminary unadjudicated safety data showed four SAEs in three patients during the six-month post-implantation period. Of those, two
SAEs in one patient were reported as device related, one SAE in one patient was reported as procedure and device related, and one SAE
in one patient was reported as unrelated to procedure or device. Final review and adjudication of SAEs and adverse events ("AEs")
have not yet been completed by an independent clinical events committee and as a result the characterization of SAEs or AEs could be
subject to change.
While additional data, including responder rates,
remains subject to ongoing review and continues to be analyzed, the Company observed in the per protocol group a 70% responder rate in
the non-CCC patient subgroup based on the Sher criteria. The per protocol group consisted of 35 patients and excluded five patients from
the mITT analysis population: two of these patients were lost to follow-up, one patient did not comply with the study protocol, and two
patients were removed from the study by the investigator, one for hostility towards staff and one having returned to continuous positive
airway pressure, therapy.
The Company expects to announce additional data
with respect to the trial as further analyses are conducted and seeks to publish the full data set from the trial in a peer-reviewed
publication. There will be no additional enrollment in the BETTER SLEEP trial. However, the Company will continue to monitor patients
in the evaluable patient population and plan to continue evaluating over the course of three years following implantation.
The data generated from this study were used
to expand the Company’s CE mark for the Genio® system to treat patients demonstrating CCC at the soft palate level, and the
first commercial Genio® implants occurred in CCC patients in Germany during the first quarter of 2022.
ACCCESS U.S. IDE STUDY SEEKING APPROVAL TO
TREAT CCC PATIENTS
In the United States, supported by the BETTER
SLEEP study data, the FDA in September 2021 granted Breakthrough Device Designation for the Genio® system in order to shorten
the approval path to treat CCC patients. Following a series of sprint discussions with the FDA regarding the design of a trial called
ACCCESS to assess the safety and efficacy of the Genio® system on CCC patients, the FDA approved the Company’s IDE application
in July 2022.
In this study, Nyxoah will implant up to 106
patients across up to 40 implant sites with co-primary efficacy endpoints of AHI responder rate, per the Sher criteria, and ODI responder
rate, both assessed at 12 months post-implant. The clinical sites are being activated, and the first patients have undergone a Genio®
implantation procedure.
B. | EUROPEAN
COMMERCIALIZATION |
During the first nine months of 2023, Nyxoah
recognized total revenue of €2.5 million, primarily in Germany. After securing DRG reimbursement in Germany during the first
quarter of 2021, Nyxoah built and expanded its German commercial organization to a total of 14 full time employees.
Nyxoah’s commercial strategy is focused
on creating a Center of Excellence ecosystem, with a high level of clinical expertise between implanting ENT surgeons and sleep physicians
who are able to provide more treatment options to their large patient pools. As of September 30, 2023, the Company has activated
46 Tier 1 sites across Germany.
The Company has also focused on entering new
European markets. The Company has secured DRG reimbursement in Switzerland, state reimbursement in Austria, and is looking into additional opportunities to enter several other countries. Nyxoah has also generated revenue in Switzerland, Austria and Spain, and the Company expects
to expand into other European countries.
Revenue
was €2.5 million for the nine months ended September 30, 2023, compared to €1.8 million for the nine months
ended September 30, 2022 with strong acceleration in Q3 2023.
Cost of goods sold was €0.9 million
for the nine months ended September 30, 2023, compared to €0.7 million cost for the nine months ended September 30,
2022.
Selling, general and administrative expenses
increased by €3.3 million or 24 % from €13.5 million for the nine months ended September 30, 2022 to €16.8 million
for the nine months ended September 30, 2023, mainly due to an increase of costs to support the commercialization of Genio®
system in Europe, scale up of the Company and also due to a start of new ERP system implementation.
Before capitalization of €7.0 million
for the nine months ended September 30, 2023 and €11.9 million for the nine months ended September 30, 2022, research
and development expenses increased by €3.1 million or 13 %, from €23.2 million for the nine months ended September 30,
2022, to €26.3 million for the nine months ended September 30, 2023, due to the combined effect of higher clinical, R&D
activities and manufacturing expenses. This increase is mainly in staff, consulting costs and in manufacturing and outsourced development
to support those activities, these increases were offset by a decrease of €2.7 million in clinical study activities due to Dream
Study.
Nyxoah
realized a net financial income of €0.8 million for the nine months ended September 30, 2023 primarily driven by the
exchange rate depreciation of dollar versus euro and by interest income related to term accounts. This compares to a net positive financial
result of €5.9 million for the nine months ended September 30, 2022, during which dollar appreciated versus euro.
Nyxoah realized a net loss of €32.3 million
for the nine months ended September 30, 2023, compared to a net loss of €17.9 million for the nine months ended September 30,
2022.
Cash and cash equivalents
On September 30, 2023, cash and cash equivalents
and financial assets totaled €72.5 million, compared to €94.9 million on December 31, 2022. The decrease in cash and cash
equivalents resulted mainly from net cash used in operating activities of €33.1 million and net cash from investing activities of
€11.2 million and offset by net cash flows from financial activities of €17.9 million due to capital increase. See note 16.
The Company expects to continue ramping up sales
in Germany as well as in other European countries where we are already present.
In the US, the Company will focus on patient
follow-up in the DREAM IDE trial resulting in reaching primary endpoints, continue to enroll the ACCCESS IDE study for CCC patients and
begin preparations to enter the US market with regulatory, manufacturing, commercial and market access readiness.
We refer to the description of risk factors in
the Company's 2022 annual report, pp. 60-83. In summary, the principal risks and uncertainties faced by us relate to our financial situation
and need for additional capital, clinical development of our product candidates, commercialization and reimbursement of our product candidates,
our dependence on third parties and on key personnel, the markets and countries in which we operate, the manufacturing of our product
candidates, legal and regulatory compliance matters, our intellectual property, our organization and operations.
5. | FORWARD-LOOKING STATEMENTS |
This interim management report contains forward-looking
statements. All statements other than present and historical facts and conditions contained in this report, including statements regarding
our future results of operations and financial position, business strategy, plans and our objectives for future operations, are forward-looking
statements. When used in this report, the words “anticipate,” “believe,” “can,” “could,”
“estimate,” “expect,” “intend,” “is designed to,” “may,” “might,”
“plan,” “potential,” “predict,” “objective,” “should,” or the negative of
these and similar expressions identify forward-looking statements. By their nature, forward-looking statements involve risks and uncertainties,
and readers are cautioned that any such forward-looking statements are not guarantees of future performance. Nyxoah’s actual results
may differ materially from those predicted by the forward-looking statements as a result of various important factors, including Nyxoah’s
expectations regarding the inherent uncertainties associated with competitive developments, clinical trial and product development activities
and regulatory approval requirements; Nyxoah’s reliance on collaborations with third parties; estimating the commercial potential
of Nyxoah’s product candidates; Nyxoah’s ability to obtain and maintain protection of intellectual property for its technologies;
Nyxoah’s limited operating history; and Nyxoah’s ability to obtain additional funding for operations and to complete the
development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks
can be found in Nyxoah’s 2022 annual report. Given these uncertainties, the reader is advised not to place any undue reliance on
such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Nyxoah expressly
disclaims any obligation to update any such forward-looking statements in this document, to reflect any change in our expectations with
regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood
that actual results will differ from those set forth in the forward-looking statements, unless specifically required by applicable law
or regulation.
Nyxoah
SA
Unaudited
condensed consolidated interim financial information as at and
for the nine months ended September 30, 2023 –
Interim consolidated statement of financial position
(unaudited)
(in thousands)
| |
| | |
As at | |
| |
Notes | | |
September 30
2023 | | |
December 31
2022 | |
ASSETS | |
| | |
| | |
| |
Non-current assets | |
| | |
| | | |
| | |
Property, plant and equipment | |
7 | | |
| 4
328 | | |
| 2
460 | |
Intangible assets | |
8 | | |
| 45
720 | | |
| 39
972 | |
Right of use assets | |
9 | | |
| 3
602 | | |
| 3
159 | |
Deferred tax asset | |
| | |
| 47 | | |
| 47 | |
Other long-term receivables | |
10 | | |
| 668 | | |
| 173 | |
| |
| | |
€ | 54
365 | | |
€ | 45
811 | |
Current assets | |
| | |
| | | |
| | |
Inventory | |
11 | | |
| 1
709 | | |
| 882 | |
Trade receivables | |
12 | | |
| 1
918 | | |
| 1
463 | |
Other receivables | |
12 | | |
| 2
437 | | |
| 1
775 | |
Other current assets | |
13 | | |
| 1
683 | | |
| 1
284 | |
Financial assets | |
15 | | |
| 59
239 | | |
| 76
968 | |
Cash and cash equivalents | |
14 | | |
| 13
250 | | |
| 17
888 | |
| |
| | |
€ | 80
236 | | |
€ | 100
260 | |
Total assets | |
| | |
€ | 134
601 | | |
€ | 146
071 | |
| |
| | |
| | | |
| | |
EQUITY AND LIABILITIES | |
| | |
| | | |
| | |
Capital and reserves | |
| | |
| | | |
| | |
Capital | |
16 | | |
| 4
926 | | |
| 4
440 | |
Share premium | |
16 | | |
| 246
130 | | |
| 228
275 | |
Share based payment reserve | |
17 | | |
| 7
468 | | |
| 5
645 | |
Other comprehensive income | |
16 | | |
| 88 | | |
| 176 | |
Retained loss | |
| | |
| (150
070) | | |
| (118
212) | |
Total equity
attributable to shareholders | |
| | |
€ | 108
542 | | |
€ | 120
324 | |
| |
| | |
| | | |
| | |
LIABILITIES | |
| | |
| | | |
| | |
Non-current liabilities | |
| | |
| | | |
| | |
Financial debt | |
18 | | |
| 8
407 | | |
| 8
189 | |
Lease liability | |
9 | | |
| 2
990 | | |
| 2
586 | |
Pension liability | |
| | |
| 75 | | |
| – | |
Provisions | |
| | |
| 125 | | |
| 59 | |
Deferred tax liability | |
| | |
| 6 | | |
| – | |
| |
| | |
€ | 11
603 | | |
€ | 10
834 | |
Current liabilities | |
| | |
| | | |
| | |
Financial debt | |
18 | | |
| 769 | | |
| 388 | |
Lease liability | |
9 | | |
| 788 | | |
| 719 | |
Trade payables | |
19 | | |
| 4
480 | | |
| 4
985 | |
Current tax liability | |
20 | | |
| 2
367 | | |
| 3
654 | |
Other payables | |
21 | | |
| 6
052 | | |
| 5
167 | |
| |
| | |
€ | 14
456 | | |
€ | 14
913 | |
Total liabilities | |
| | |
€ | 26
059 | | |
€ | 25
747 | |
Total equity
and liabilities | |
| | |
€ | 134
601 | | |
€ | 146
071 | |
The accompanying notes are an integral part
of these condensed consolidated interim financial statements.
NYXOAH
SA
Unaudited
condensed consolidated interim financial information as at and
for the nine months ended September 30, 2023 -
Interim consolidated statements of loss and other comprehensive loss
(unaudited)
(in thousands)
| |
| | |
For the
three months ended September 30 | | |
For the
nine months ended September 30 | |
| |
Notes | | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenue | |
23 | | |
| 976 | | |
| 182 | | |
| 2
524 | | |
| 1
777 | |
Cost of goods sold | |
23 | | |
| (336 | ) | |
| (63 | ) | |
| (930 | ) | |
| (685 | ) |
Gross profit | |
| | |
€ | 640 | | |
€ | 119 | | |
€ | 1
594 | | |
€ | 1
092 | |
Research and Development Expense | |
23 | | |
| (6
568 | ) | |
| (4
221 | ) | |
| (19
330 | ) | |
| (11
286 | ) |
Selling, General and Administrative Expense | |
23 | | |
| (5
058 | ) | |
| (4
763 | ) | |
| (16
794 | ) | |
| (13
492 | ) |
Other income/(expense) | |
| | |
| – | | |
| 87 | | |
| 265 | | |
| 237 | |
Operating loss for the period | |
| | |
€ | (10
986 | ) | |
€ | (8
778 | ) | |
€ | (34
265 | ) | |
€ | (23
449 | ) |
Financial income | |
25 | | |
| 2
178 | | |
| 5
127 | | |
| 3
592 | | |
| 11
372 | |
Financial expense | |
26 | | |
| (1
033 | ) | |
| (2
524 | ) | |
| (2
765 | ) | |
| (5
473 | ) |
Loss for the period before taxes | |
| | |
€ | (9
841 | ) | |
€ | (6
175 | ) | |
€ | (33
438 | ) | |
€ | (17
550 | ) |
Income taxes | |
20 | | |
| 2
229 | | |
| (65 | ) | |
| 1
119 | | |
| (379 | ) |
Loss for the period | |
| | |
€ | (7
612 | ) | |
€ | (6
240 | ) | |
€ | (32
319 | ) | |
€ | (17
929 | ) |
| |
| | |
| | | |
| | | |
| | | |
| | |
Loss attributable to equity holders | |
| | |
€ | (7
612 | ) | |
€ | (6
240 | ) | |
€ | (32
319 | ) | |
€ | (17
929 | ) |
Other comprehensive loss | |
| | |
| | | |
| | | |
| | | |
| | |
Items that may be subsequently reclassified to profit
or loss (net of tax) | |
| | |
| | | |
| | | |
| | | |
| | |
Currency translation differences | |
| | |
| (10 | ) | |
| 100 | | |
| (88 | ) | |
| (14 | ) |
Total comprehensive loss for the
year, net of tax | |
| | |
€ | (7
622 | ) | |
€ | (6
140 | ) | |
€ | (32
407 | ) | |
€ | (17
943 | ) |
Loss attributable to equity holders | |
| | |
€ | (7
622 | ) | |
€ | (6
140 | ) | |
€ | (32
407 | ) | |
€ | (17
943 | ) |
| |
| | |
| | | |
| | | |
| | | |
| | |
Basic Loss Per Share (in EUR) | |
27 | | |
€ | (0.266 | ) | |
€ | (0.242 | ) | |
€ | (1.166 | ) | |
€ | (0.695 | ) |
Diluted Loss Per Share (in EUR) | |
27 | | |
€ | (0.266 | ) | |
€ | (0.242 | ) | |
€ | (1.166 | ) | |
€ | (0.695 | ) |
The accompanying notes are an integral part
of these condensed consolidated interim financial statements
NYXOAH
SA
Unaudited
condensed consolidated interim financial information as at and
for the nine months ended, September 30 2023 -
Interim consolidated statements of changes in equity
(unaudited)
(in thousands)
| |
Attributable
to owners of the parent | |
| |
Common
shares | | |
Share
premium | | |
Share
based payment reserve | | |
Other
comprehensive income | | |
Retained
loss | | |
Total | |
Balance at January 1, 2023 | |
€ | 4
440 | | |
€ | 228
275 | | |
€ | 5
645 | | |
€ | 176 | | |
€ | (118
212 | ) | |
| 120
324 | |
Loss for the period | |
| – | | |
| – | | |
| – | | |
| – | | |
| (32
319 | ) | |
| (32
319 | ) |
Other comprehensive loss for the period | |
| – | | |
| – | | |
| – | | |
| (88 | ) | |
| – | | |
| (88 | ) |
Total comprehensive loss for the
period | |
| – | | |
| – | | |
| – | | |
€ | (88 | ) | |
€ | (32
319 | ) | |
€ | (32
407 | ) |
Equity-settled share-based payments | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Granted during the period | |
| – | | |
| – | | |
| 2
284 | | |
| – | | |
| – | | |
| 2
284 | |
Forfeited during the period | |
| – | | |
| – | | |
| (461 | ) | |
| – | | |
| 461 | | |
| – | |
Transaction cost | |
| – | | |
| (337 | ) | |
| – | | |
| – | | |
| – | | |
| (337 | ) |
Issuance of shares for cash | |
| 486 | | |
| 18
192 | | |
| – | | |
| – | | |
| – | | |
| 18
678 | |
Total transactions with owners of
the company recognized directly in equity | |
| 486 | | |
| 17
855 | | |
| 1
823 | | |
| – | | |
| 461 | | |
| 20
625 | |
Balance at September 30, 2023 | |
€ | 4
926 | | |
€ | 246
130 | | |
€ | 7
468 | | |
€ | 88 | | |
€ | (150
070 | ) | |
€ | 108
542 | |
| |
Attributable
to owners of the parent | |
| |
Common
shares | | |
Share
premium | | |
Share
based payment reserve | | |
Other
comprehensive income | | |
Retained
loss | | |
Total | |
Balance at January 1, 2022 | |
€ | 4
427 | | |
€ | 228
033 | | |
€ | 3
127 | | |
€ | 202 | | |
€ | (87
167 | ) | |
€ | 148
622 | |
Loss for the period | |
| – | | |
| – | | |
| – | | |
| – | | |
| (17
929 | ) | |
| (17
929 | ) |
Other comprehensive income for the period | |
| – | | |
| – | | |
| – | | |
| (14 | ) | |
| – | | |
| (14 | ) |
Total comprehensive loss for the
period | |
| – | | |
| – | | |
| – | | |
€ | (14 | ) | |
€ | (17
929 | ) | |
€ | (17
943 | ) |
Equity-settled share-based payments | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Granted during the period | |
| – | | |
| – | | |
| 2
136 | | |
| – | | |
| – | | |
| 2
136 | |
Exercised during the period | |
| 6 | | |
| 242 | | |
| (38 | ) | |
| – | | |
| 38 | | |
| 248 | |
Issuance of shares for cash | |
| 7 | | |
| – | | |
| – | | |
| – | | |
| – | | |
| 7 | |
Total transactions
with owners of the company recognized directly in equity | |
| 13 | | |
| 242 | | |
| 2
098 | | |
| – | | |
| 38 | | |
| 2
391 | |
Balance at September 30, 2022 | |
€ | 4
440 | | |
€ | 228
275 | | |
€ | 5
225 | | |
€ | 188 | | |
€ | (105
058 | ) | |
€ | 133
070 | |
The accompanying notes are an integral part
of these condensed consolidated interim financial statements.
Nyxoah
SA
Unaudited
condensed consolidated interim financial information as at and
for the nine months ended September 30, 2023 –
Interim consolidated statements of cash flows
(unaudited)
(in thousands)
| |
| | |
For the
nine months ended September 30 | |
| |
Notes | | |
2023 | | |
2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES | |
| | |
| | | |
| | |
Loss before tax for the year | |
| | |
€ | (33
438) | | |
€ | (17
550 | ) |
Adjustments for | |
| | |
| | | |
| | |
Finance income | |
| | |
| (3
592) | | |
| (11
372 | ) |
Finance expenses | |
| | |
| 2
765 | | |
| 5
473 | |
Depreciation and impairment
of property, plant and equipment and right-of-use assets | |
7,
9 | | |
| 916 | | |
| 832 | |
Amortization of intangible assets | |
8 | | |
| 720 | | |
| 607 | |
Share-based payment transaction expense | |
17 | | |
| 2
284 | | |
| 2
136 | |
Increase/(Decrease) in provisions | |
| | |
| 141 | | |
| 36 | |
Other non-cash items | |
| | |
| 4 | | |
| (353 | ) |
Cash generated before changes in
working capital | |
| | |
€ | (30
200) | | |
€ | (20
191 | ) |
Changes in working capital | |
| | |
| | | |
| | |
Decrease/(Increase) in inventory | |
11 | | |
| (827 | ) | |
| (248 | ) |
(Increase)/Decrease in trade and other
receivables | |
12 | | |
| (627 | ) | |
| 1
100 | |
Increase/(Decrease) in trade and other
payables | |
19,21 | | |
| (929 | ) | |
| 1
265 | |
Cash generated from changes in operations | |
| | |
€ | (32
583) | | |
€ | (18
074 | ) |
Income tax paid | |
| | |
| (517 | ) | |
| (314 | ) |
Net cash from / (used in) operating
activities | |
| | |
€ | (33
100) | | |
€ | (18
388 | ) |
CASH FLOWS FROM INVESTING ACTIVITIES | |
| | |
| | | |
| | |
Purchases of property, plant and equipment | |
7 | | |
| (2
264) | | |
| (484 | ) |
Capitalization of intangible assets | |
8 | | |
| (6
961) | | |
| (11
774 | ) |
Purchase of financial assets - current | |
15 | | |
| (71
535) | | |
| (44
032 | ) |
Proceeds from sale of financial assets - current | |
15 | | |
| 90
623 | | |
| 24
582 | |
Interest income on financial assets | |
| | |
| 1
384 | | |
| 63 | |
Net cash from / (used in) investing
activities | |
| | |
€ | 11
247 | | |
€ | (31
645 | ) |
CASH FLOWS FROM FINANCING ACTIVITIES | |
| | |
| | | |
| | |
Payment of principal portion of lease
liabilities | |
9 | | |
| (620 | ) | |
| (497 | ) |
Repayment of other loan | |
| | |
| (63 | ) | |
| (62 | ) |
Interests paid | |
| | |
| (26 | ) | |
| (185 | ) |
Repayment of recoverable cash advance | |
18 | | |
| – | | |
| (220 | ) |
Proceeds from issuance of shares, net
of transaction costs | |
16 | | |
| 18
341 | | |
| 255 | |
Other financial
costs | |
| | |
| (56 | ) | |
| (55 | ) |
Net cash from / (used
in) financing activities | |
| | |
€ | 17
576 | | |
€ | (764 | ) |
Movement in cash and cash equivalents | |
| | |
€ | (4
277) | | |
€ | (50
797 | ) |
Effect of exchange
rates on cash and cash equivalents | |
| | |
| (361 | ) | |
| 5
165 | |
Cash and cash equivalents at January 1 | |
14 | | |
€ | 17
888 | | |
€ | 135
509 | |
Cash and cash equivalents at September 30 | |
14 | | |
€ | 13
250 | | |
€ | 89
877 | |
The
accompanying notes are an integral part of these condensed consolidated interim financial statements.
Nyxoah
SA
Notes
to the unaudited condensed interim consolidated financial information
1. General information
Nyxoah SA (the “Company”) is a public
listed company with limited liability (naamloze vennootschap/société anonyme) incorporated and operating under the laws
of Belgium and is domiciled in Belgium. The Company is registered with the legal entities register (Brabant Walloon) under enterprise
number 0817.149.675. The Company’s registered office is in Rue Edouard Belin 12, 1435 Mont-Saint-Guibert, Belgium.
The
Company is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive
Sleep Apnea, or OSA. Our lead solution is the Genio® system, a CE-Marked, patient-centric, minimally invasive,
next generation hypoglossal neurostimulations therapy for OSA. OSA is the world’s most common sleep disordered breathing condition
and is associated with increased mortality risk and comorbidities including cardiovascular diseases, depression and stroke.
The
Genio® system is the first neurostimulation system for the treatment of OSA to include a battery-free and leadless neurostimulator
capable of delivering bilateral hypoglossal nerve stimulation to keep the upper airway open. The product is intended to be used as a
second-line therapy to treat moderate to severe OSA patients who have either not tolerated, failed or refused conventional therapy, including
Continuous Positive Airway Pressure, or CPAP, which, despite its proven efficacy, is associated with many limitations, meaning compliance
is a serious challenge. In addition, other second-line treatments are more suitable to treat mild to moderate OSA (such as oral devices)
or highly invasive. Compared to other hypoglossal nerve stimulation technologies for the treatment of OSA, the Genio®
system is a disruptive, differentiating technology that targets a clear unmet medical need thanks to its minimally invasive and
quick implantation technique, its external battery and its ability to stimulate the two branches of the hypoglossal nerve.
Obstructive sleep apnea is the world’s
most common sleep disordered breathing condition. OSA occurs when the throat and tongue muscles and soft tissues relax and collapse.
It makes a person stop breathing during sleep, while the airway repeatedly becomes partially (hypopnea) or completely (apnea) blocked,
limiting the amount of air that reaches the lungs. During an episode of apnea or hypopnea, the patient’s oxygen level drops, which
leads to sleep interruptions.
Nyxoah SA has four wholly owned subsidiaries:
Nyxoah Ltd, a subsidiary of the Company since October 21, 2009 (located in Israel and incorporated on January 10, 2008 under
the name M.L.G. Madaf G. Ltd), Nyxoah Pty Ltd since February 1, 2017 (located in Australia), Nyxoah Inc. since May 14,
2020 (located in the USA) and Nyxoah GmbH since July 26, 2023 (located in Germany).
The interim condensed consolidated financial
statements of Nyxoah SA and its subsidiaries (collectively, the Group) as of September 30, 2023 and for the three and nine months
ended September 30, 2023, have been authorized for issue on November 8, 2023 by the Board of Directors of the Company.
2. Significant accounting policies
Basis of Preparation of the interim condensed consolidated financial
statements
The Company’s interim condensed consolidated
financial statements have been prepared in accordance with International Accounting Standard 34 – Interim Financial Reporting (“IFRS”),
as issued by the International Accounting Standards Board (IASB). They do not include all the information required for complete annual
financial statements and should be read in conjunction with the Company’s last annual consolidated financial statements as at and
for the year ended December 31, 2022.
Except for the application of standards, interpretations
and amendments being mandatory as of January 1, 2023, the accounting policies used for the preparation of the interim condensed
consolidated financial statements are consistent with those used for the preparation of the Company’s annual consolidated financial
statements as of and for the year ended December 31, 2022.
The consolidated financial statements are presented
in thousands of Euros (€) and all values are rounded to the nearest thousands, except when otherwise indicated (e.g. € million).
The preparation of the interim condensed consolidated
financial statements requires the use of certain critical accounting estimates. It also requires management to exercise its judgment
in the process of applying the Company’s accounting policies. The areas involving a higher degree of judgement or complexity, are
areas where assumptions and estimates are significant to the consolidated financial statements. The critical accounting estimates used
in the preparation of the interim consolidated financial statements are consistent with those followed in the preparation of the Company’s
annual consolidated financial statements as of and for the year ended December 31, 2022.
Going concern principle
The
Unaudited Interim Condensed Consolidated Financial Statements have been prepared on a going concern basis. As at September 30, 2023,
the Company had cash and cash equivalents of €13.3 million and financial assets of €59.2 million. Based on cash flow
forecasts for the remaining period of 2023 and 2024, which include significant expenses and cash outflows in relation to – among
others – the ongoing clinical trials, the continuation of research and development project, and the scaling up of the Company’s
manufacturing facilities. The Company believes that this cash position will be sufficient to meet the Company’s capital
requirements and fund its operations for at least 12 months as from the date these financials are authorized for issuance.
New and amended standards and interpretations applicable
Effective for the annual
periods beginning on January 1, 2023
The Group has not early adopted any standard,
interpretation or amendment that has been issued but is not yet effective.
Several amendments and interpretations apply
for the first time in 2023, but do not have an impact on the interim condensed consolidated financial statements of the Company:
| - | IFRS
17 Insurance Contracts (applicable for annual periods beginning on or after January 1,
2023) |
| - | Amendments
to IFRS 17 Insurance contracts: Initial Application of IFRS 17 and IFRS 9 – Comparative
Information (applicable for annual periods beginning on or after January 1, 2023) |
| - | Amendments
to IAS 1 Presentation of Financial Statements and IFRS Practice Statement 2: Disclosure of
Accounting Policies (applicable for annual periods beginning on or after January 1,
2023) |
| - | Amendments
to IAS 8 Accounting policies, Changes in Accounting Estimates and Errors: Definition of Accounting
Estimates (applicable for annual periods beginning on or after January 1, 2023) |
| - | Amendments
to IAS 12 Income Taxes: Deferred Tax related to Assets and Liabilities arising from a Single
Transaction (applicable for annual periods beginning on or after January 1, 2023) |
| - | Amendments
to IAS 12 Income taxes: International Tax Reform – Pillar Two Model Rules (effective
immediately – disclosures are required for annual periods beginning on or after 1 January 2023).
The Group will not be subject to Pillar Two Model rules. |
3. Critical accounting estimates and assumptions
The preparation of interim financial statements
in accordance with IFRS requires management to make judgments, estimates and assumptions that may significantly affect the reported amounts
of revenues, expenses, assets and liabilities, and the disclosure of contingent liabilities at the end of the reporting period.
Refer to the disclosure note 5 from the Group’s
2022 year-end consolidated financial statements for further details about the main critical accounting estimates and assumptions.
4. Segment reporting
Based on the organizational structure, as well
as the nature of financial information available and reviewed by the Company’s chief operating decision makers to assess performance
and make decisions about resource allocations, the Company has concluded that its total operations represent one reportable segment.
The chief operating decision maker is the CEO.
5. Fair Value
The carrying amount of cash and cash equivalents,
trade receivables, other receivables, other current assets and financial assets approximate their value due to their short-term character.
The carrying value of current liabilities approximates
their fair value due to the short-term character of these instruments. The fair value of non-current liabilities (financial debt and
other non-current liabilities), excluding the derivative financial liabilities, is evaluated based on their interest rates and maturity
date. These instruments have fixed interest rates and their fair value measurements are subject to changes in interest rates. The fair
value measurement is classified as level 3.
The derivative financial liabilities and assets
which consist of foreign currency options and foreign currency forwards are measured at fair value through profit and loss. Fair value
is determined by the financial institution and is based on foreign currency forwards rates and the maturity of the instrument.
| |
Carrying
value | | |
Fair value | |
(in EUR 000) | |
As
at September 30, 2023 | | |
As
at December 31, 2022 | | |
As
at September 30, 2023 | | |
As
at December 31, 2022 | |
Financial Assets | |
| | | |
| | | |
| | | |
| | |
Other long-term receivables (level 3) | |
| 668 | | |
| 173 | | |
| 668 | | |
| 173 | |
Trade and other receivables (level 3) | |
| 4
334 | | |
| 3
237 | | |
| 4
334 | | |
| 3
237 | |
Foreign currency forwards (level 2) | |
| 21 | | |
| 1 | | |
| 21 | | |
| 1 | |
Other current assets (level 3) | |
| 1
683 | | |
| 1
284 | | |
| 1
683 | | |
| 1
284 | |
Cash and cash equivalents (level 1) | |
| 13
250 | | |
| 17
888 | | |
| 13
250 | | |
| 17
888 | |
Financial assets (level 1) | |
| 59
239 | | |
| 76
968 | | |
| 59
239 | | |
| 76
968 | |
| |
Carrying
value | | |
Fair value | |
(in EUR 000) | |
As
at September 30, 2023 | | |
As
at December 31, 2022 | | |
As
at September 30, 2023 | | |
As
at December 31, 2022 | |
Financial liabilities | |
| | | |
| | | |
| | | |
| | |
Financial debt (level 3) | |
| 84 | | |
| 146 | | |
| 80 | | |
| 138 | |
Foreign currency option (level 2) | |
| 1
013 | | |
| 10 | | |
| 1
013 | | |
| 10 | |
Recoverable cash advances (level 3) | |
| 9
092 | | |
| 8
431 | | |
| 9
092 | | |
| 8
431 | |
Trade and other payables (level 1 and 3) | |
| 9
519 | | |
| 10
142 | | |
| 9
519 | | |
| 10
142 | |
6. Subsidiaries
For all periods that are mentioned in this report,
the Company owns 100% of the shares of Nyxoah LTD, an Israeli company located in Tel-Aviv that was incorporated in 2009 and has a share
capital of NIS 1.00.
The Company also owns 100% of the shares of Nyxoah
PTY LTD, an Australian Company located in Collingwood that was incorporated in 2017 and has a share capital of AUD 100.
In May 2020, the Company incorporated Nyxoah
Inc, an US-based company located in Delaware with a share capital of USD 1.00. The Company owns 100% of the shares of Nyxoah Inc.
In
July 2023, the Company acquired Nyxoah GmbH, a German company located in Eschborn with a share capital of EUR 25,000. Nyxoah
GmbH was incorporated on May 11, 2023. Except for the minimum capital of EUR 25,000, Nyxoah GmbH has no assets or liabilities and
no business had been conducted by it. The Company owns 100% of the shares of Nyxoah GmbH.
7. Property, Plant and Equipment
The total acquisitions for the nine months ended
September 30, 2023 amount to €2.3 million (2022: €484,000) and were mainly related to laboratory equipment, furniture
and office equipment. Assets under construction were transferred to leasehold improvements for an amount of €0.6 million and
to laboratory equipment for an amount of €139,000.
The depreciation charge amounts to €350,000
in 2023 and to €296,000 in 2022 for the nine months ended September 30.
8. Intangible assets
(in EUR 000) | |
Development
cost | | |
Patents
and
licenses | | |
Total | |
Cost | |
| | | |
| | | |
| | |
Opening value at January 1, 2022 | |
| 25
609 | | |
| 591 | | |
| 26
200 | |
Additions | |
| 11
774 | | |
| – | | |
| 11
774 | |
Cost at September 30, 2022 | |
| 37
383 | | |
| 591 | | |
| 37
974 | |
Opening value at January 1, 2023 | |
| 41
073 | | |
| 591 | | |
| 41
664 | |
Additions | |
| 6
961 | | |
| – | | |
| 6
961 | |
Other | |
| (493 | ) | |
| – | | |
| (493 | ) |
Cost at September 30, 2023 | |
| 47
541 | | |
| 591 | | |
| 48
132 | |
Amortization | |
| | | |
| | | |
| | |
Opening amortization at January 1, 2022 | |
| (837 | ) | |
| (42 | ) | |
| (879 | ) |
Amortization | |
| (575 | ) | |
| (32 | ) | |
| (607 | ) |
Amortization at September 30, 2022 | |
| (1
412 | ) | |
| (74 | ) | |
| (1
486 | ) |
Opening amortization at January 1, 2023 | |
| (1
608 | ) | |
| (84 | ) | |
| (1
692 | ) |
Amortization | |
| (688 | ) | |
| (32 | ) | |
| (720 | ) |
Amortization at September 30, 2023 | |
| (2
296 | ) | |
| (116 | ) | |
| (2
412 | ) |
Net book value at September 30, 2022 | |
| 35
971 | | |
| 517 | | |
| 36
488 | |
Net book value at September 30, 2023 | |
| 45
245 | | |
| 475 | | |
| 45
720 | |
There is only one development project: The Genio®
system. The Company started amortizing the first-generation Genio® system in 2021. The amortization amounted to
€0.7 million for the nine months ended September 30, 2023 (2022: €0.6 million) and is included in research and
development expense.
The Company continues to incur in 2023 development
expenses with regard to the improved second-generation Genio® system and clinical trials to obtain additional regulatory
approvals in certain countries or to be able to sell the Genio® System in certain countries. The total capitalized development
expenses amounted to €7.0 million and €11.8 million for the nine months ended September 30, 2023, and 2022,
respectively.
The line Other relates to R&D tax incentive
in Belgium. We refer to note 10 for more details.
9. Right of use assets and lease liabilities
For the nine months ended September 30,
2023, the Company entered into new lease agreements for €321,000 (2022: €0.7 million). On top of that an existing lease
contract has been extended, resulting in an increase of the RoU asset and lease liability with €0.8 million. The repayments
of lease liabilities amounted to €0.6 million (2022: €497,000). The depreciations on the right of use assets amounted
to €0.6 million and €0.5 million for the nine months ended September 30, 2023, and 2022, respectively.
10. Other long-term receivables
The increase in other long-term receivables is
due to an R&D tax incentive in Belgium for an amount of 493,000 € in relation to certain development activities and clinical
trials. The Company recognizes the research and development incentive as a long-term receivable (expected to be received in cash in 2026)
and as a deduction from the carrying amount of the intangible asset.
11. Inventory
| |
As at | |
(in EUR 000) | |
September 30,
2023 | | |
December 31,
2022 | |
Raw materials | |
| 534 | | |
| 498 | |
Work in progress | |
| 930 | | |
| 100 | |
Finished goods | |
| 245 | | |
| 284 | |
Total Inventory | |
| 1
709 | | |
| 882 | |
The increase in inventory is due to increasing
activities to prepare for the commercialization and further scale-up of the Company in 2023. For the period ended September 30,
2023 and the year ended December 31, 2022 the Company did not recognize any expenses for inventory write-offs since the inventory
level is expected to be sold in the foreseeable future.
12. Trade and Other receivables
| |
As at | |
(in EUR 000) | |
September 30,
2023 | | |
December 31,
2022 | |
Trade receivables | |
| 1
918 | | |
| 1
463 | |
R&D incentive receivable (Australia) | |
| 681 | | |
| 346 | |
VAT receivable | |
| 706 | | |
| 847 | |
Current tax receivable | |
| 626 | | |
| 159 | |
Foreign currency swaps | |
| 21 | | |
| 1 | |
Other | |
| 403 | | |
| 422 | |
Total trade and other receivables | |
| 4
355 | | |
| 3
238 | |
The increase of €1.1 million in trade
and other receivables is mainly due to an increase in trade receivables by €455,000, an increase in current tax receivable by €467,000
and an increase in R&D incentive receivables by €335,000 which is partially offset with a decrease by €141,000 in VAT receivable.
The Company may include unbilled receivables
in its accounts receivable balance. Generally, these receivables represent earned revenue from products delivered to customers, which
will be billed in the next billing cycle. All amounts are considered collectible and billable. As at December 31, 2022 and September 30,
2023, there were no unbilled receivables included in the trade receivables.
R&D
incentive receivables relates to incentives received in Australia as support to the clinical trials and the development of the Genio®
system.
The current tax receivable relates to excess
payment of corporate income tax in Israel, US and Belgium. The increase by €188,000 in US can be explained by the finalization of
the R&D tax credit study during Q3 2023. We refer to note 20 for more details. On top of that the increase in Belgium by €347,000
is explained by an increase in withholding tax on interest for term deposit accounts.
Other mainly relates advance payments and withholding
tax to be received related to Belgian R&D employees.
13. Other current assets
The increase of €399,000 in other current
assets as at September 30, 2023 is due to increase in accrued interest on the term deposits by €0,6 million which is partly
offset by a decrease in prepaid expenses by €230,000.
14. Cash and cash equivalents
| |
As at | |
(in EUR 000) | |
September 30,
2023 | | |
December 31,
2022 | |
Short term deposit | |
| 6
033 | | |
| 36 | |
Current accounts | |
| 7
217 | | |
| 17
852 | |
Total cash and cash equivalents | |
| 13
250 | | |
| 17
888 | |
Cash
and cash equivalents decreased to €13.3 million as at September 30, 2023, compared to €17.9 million as
at December 31, 2022 with a decrease of current accounts by €10.6 million which is partially offset by an increase of
short term deposits (less than 3 months) by €6.0 million
15. Financial assets
Current financial assets relate to term accounts
with an initial maturity longer than 3 months but less than 12 months measured at amortized costs.
In 2023, the Company entered into USD term deposits
and US Treasury bills for a total amount $US 66.0 million (€60.5 million) and €11.0 million. During the period ended as at
September 30, 2023, $US 47.0 million (€43.6 million) and €47.0 million reached maturity and is subsequently held as cash.
As per September 30, 2023, the current financial
assets consists of $US 48.9 million (€46.2 million), which could generate a foreign currency exchange gain or loss in the financial
results in accordance with the fluctuations of the USD/EUR exchange rate as the Company’s functional currency is EUR, and €13.0
million. The total amount of term deposits as per September 30, 2023, amounts to €59.2 million.
16. Capital, Share Premium, Reserves
16.1. Capital and share premium
The number of shares and the par value in the
paragraph below take into account resolutions adopted by the shareholders’ meeting of February 21, 2020. All existing preferred
shares were converted into common shares, and then a share split of 500:1 was approved by the shareholders’ meeting. The tables
and comments below reflect the number of shares after the share split of 500:1 as of January 1, 2020.
As part of the IPO on September 21, 2020,
the Company incurred direct-attributable transaction costs of €6.5 million which have been deducted from the share premium.
As part of the IPO on July 7, 2021, the
Company incurred direct-attributable transaction costs of €7.6 million which have been deducted from the share premium.
As
of September 30, 2023, the share capital of the Company amounts to €4.9 million represented by 28,673,985 shares,
and the share premium amounts to €260.6 million (before deduction of the transaction costs).
Evolution of the share capital and share premium
over the nine months ended September 30, 2023 and 2022:
(Number of shares except otherwise stated) | |
Common
shares | | |
Total
of shares | | |
Par
value (EUR) | | |
Share
capital | | |
Share
premium | |
January 1, 2022 | |
| 25
772 359 | | |
| 25
772 359 | | |
| 0.17 | | |
| 4
427 | | |
| 242
198 | |
February 10, 2022 - Exercise warrants | |
| 25
000 | | |
| 25
000 | | |
| 0.17 | | |
| 4 | | |
| 125 | |
June 8, 2022 - Capital increase in cash | |
| 38
920 | | |
| 38
920 | | |
| 0.17 | | |
| 7 | | |
| – | |
September 30, 2022 - Exercise warrants | |
| 10
000 | | |
| 10
000 | | |
| 0.17 | | |
| 2 | | |
| 117 | |
September 30, 2022 | |
| 25
846 279 | | |
| 25
846 279 | | |
| 0.17 | | |
| 4
440 | | |
| 242
440 | |
December 31, 2022 | |
| 25
846 279 | | |
| 25
846 279 | | |
| 0.17 | | |
| 4
440 | | |
| 242
440 | |
March 29, 2023 - Capital increase in cash | |
| 393
162 | | |
| 393
162 | | |
| 0.17 | | |
| 68 | | |
| 2
481 | |
March 30, 2023 - Capital increase in cash | |
| 2
047 544 | | |
| 2
047 544 | | |
| 0.17 | | |
| 351 | | |
| 12
999 | |
April 13, 2023 - Capital increase in cash | |
| 375
000 | | |
| 375
000 | | |
| 0.17 | | |
| 65 | | |
| 2
651 | |
July 14, 2023 - Exercise warrants | |
| 2
000 | | |
| 2
000 | | |
| 0.17 | | |
| – | | |
| 10 | |
August 29, 2023 - Exercise warrants | |
| 10
000 | | |
| 10
000 | | |
| 0.17 | | |
| 2 | | |
| 50 | |
September 30, 2023 | |
| 28
673 985 | | |
| 28
673 985 | | |
| 0.17 | | |
| 4
926 | | |
| 260
631 | |
On March 29, 2023, the Company issued 393,162
new shares for an aggregate capital increase of €2.5 million (including share premium). The Company raised $2.8 million in gross
proceeds pursuant to the Company’s $50 million at-the-market ("ATM") program established on December 22, 2022 at
an issue price equal to the market price on the Nasdaq Global Market at the time of the sale. The shares were purchased by historical
Nyxoah shareholder Cochlear Limited, and the proceeds will be used for general corporate purposes.
On March 30, 2023, the Company raised €13.35
million private placement financing from the sale of 2,047,544 new ordinary shares at a price per share of €6.52 (approximately
U.S. $7.10 at current exchange rates), the closing price on Euronext Brussels on March 23, 2023. Gross proceeds total €13.35
million (approximately U.S. $15 million at current exchange rates) and will be used for general corporate purposes.
On
April 13, 2023, the Company issued 375,000 new shares for an aggregate capital increase of €2.7 million (including share
premium). The Company raised $3.0 million in gross proceeds pursuant to the Company’s $50 million at-the-market ("ATM")
program established on December 22, 2022 at an issue price equal to the market price on the Nasdaq Global Market at the time of
the sale. The proceeds will be used for general corporate purposes.
As part of above capital increases, the Company
incurred direct-attributable transaction costs of €337,000 which have been deducted from the share premium. The proceeds from the
capital increase net of transaction costs amounted to €18.3 million.
On
July 14, 2023, pursuant to the exercise of warrants, the Company issued 2,000 new shares for an aggregate capital increase of
€10,000 (including share premium).
On
August 29, 2023, pursuant to the exercise of warrants, the Company issued 10,000 new shares for an aggregate capital increase
of €52,000 (including share premium).
16.2. Reserves
The reserves include the share-based payment
reserve (see note 17 ), other comprehensive income and the retained loss. Retained loss is comprised of primarily accumulated losses,
other comprehensive income is comprised of currency translation reserves and remeasurements of post-employment benefit obligations.
The movement in other comprehensive income for
the nine months ended September 30, 2023 and 2022 is detailed in the table below:
(in EUR 000) | |
Currency
translation reserve | | |
Post-
employment benefit obligations | | |
Total | |
Opening value at January 1, 2022 | |
| 270 | | |
| (68 | ) | |
| 202 | |
Currency translation differences | |
| (14 | ) | |
| – | | |
| (14 | ) |
Total other comprehensive income
at September 30, 2022 | |
| 256 | | |
| (68 | ) | |
| 188 | |
Opening value at January 1, 2023 | |
| 174 | | |
| 2 | | |
| 176 | |
Currency translation differences | |
| (88 | ) | |
| – | | |
| (88 | ) |
Total other comprehensive income
at September 30, 2023 | |
| 86 | | |
| 2 | | |
| 88 | |
17. Share-Based compensation
Equity-settled share-based payment transactions
As of September 30, 2023, the Company has
five outstanding equity-settled share-based incentive plans, including (i) the 2016 warrants plan (the 2016 Plan), (ii) the
2018 warrants plan (the 2018 Plan), (iii) the 2020 warrants plan (the 2020 Plan), (iv) the 2021 warrants plan (the 2021 plan)
and (v) the 2022 warrants plan (the 2022 plan). The Company had an extraordinary shareholders’ meeting on February 21,
2020 where it was decided to achieve a share split in a ratio of 500:1. Per warrant issued before February 21, 2020, 500 common
shares will be issuable. For presentation purposes the tables and comments below reflect the number of shares the warrants give right
to across all plans.
In accordance with the terms of the various plans,
all warrants that had not yet vested before, vested on September 7, 2020, i.e. ten business days prior to the closing of the IPO
on September 21, 2020.
Number
of shares (after share split) warrants give right to across all plans | |
| 2023 | | |
| 2022 | |
Outstanding at January 1 | |
| 1
416 490 | | |
| 993
490 | |
Granted | |
| 475
862 | | |
| 461
500 | |
Forfeited/Cancelled | |
| (182
500) | | |
| (14
125) | |
Exercised | |
| (12
000) | | |
| (25
000) | |
Outstanding as at September 30 | |
| 1
697 852 | | |
| 1
415 865 | |
Exercisable as at September 30 | |
| 1
043 771 | | |
| 779
966 | |
The followings warrants from the 2021 warrant
plan have been granted in 2023:
| - | March 24,
2023: 200,862 warrants; |
| - | April 12,
2023: 100,000 warrants; |
| - | June 14,
2023: 161,398 warrants. |
On June 14, 2023, 13,602 warrants were granted
from the 2022 warrant plan.
The following tables provide the input to the
Black-Scholes model for warrants granted in 2018, 2020, 2021, 2022 and 2023 related to the 2016 warrant plan, the 2018 warrant plan,
the 2020 warrant plan, the 2021 warrant plan and the 2022 warrant plan. The tables and notes uses as a basis, the number of shares the
warrants give right to across all plans.
| |
Plan
2016 (grant 2018) | | |
Plan
2018 (grant 2018) | | |
Plan
2018 (grant 2020) | | |
Plan
2020 (grant 2020) | | |
Plan
2021 (grant Sept 17 2021) | |
Return Dividend | |
| 0 | % | |
| 0 | % | |
| 0 | % | |
| 0 | % | |
| 0 | % |
Expected volatility | |
| 66.92 | % | |
| 56.32 | % | |
| 56.32 | % | |
| 56.32 | % | |
| 51.30 | % |
Risk-free interest rate | |
| 0.35 | % | |
| -0.20 | % | |
| -0.20 | % | |
| -0.20 | % | |
| -0.36 | % |
Expected life | |
| 3 | | |
| 3 | | |
| 3 | | |
| 3 | | |
| 3 | |
Exercise price | |
| 5.17 | | |
| 6.52 | | |
| 11.94 | | |
| 11.94 | | |
| 25.31 | |
Stock price | |
| 1.09 | | |
| 10.24 | | |
| 10.20 | | |
| 10.20 | | |
| 25.75 | |
Fair value | |
| 0.10 | | |
| 5.30 | | |
| 3.31 | | |
| 3.31 | | |
| 9.22 | |
| |
Plan
2021 (grant Oct 27 2021) | | |
Plan
2021 (grant Feb 21 2022) | | |
Plan
2021 (grant Feb 21 2022) | | |
Plan
2021 (grant Feb 21 2022) | | |
Plan
2021 (grant May 14 2022) | |
Return Dividend | |
| 0 | % | |
| 0 | % | |
| 0 | % | |
| 0 | % | |
| 0 | % |
Expected volatility | |
| 51.50 | % | |
| 49.80 | % | |
| 49.80 | % | |
| 49.80 | % | |
| 49.80 | % |
Risk-free interest rate | |
| -0.18 | % | |
| 0.37 | % | |
| 0.37 | % | |
| 0.50 | % | |
| 1.06 | % |
Expected life | |
| 3 | | |
| 3 | | |
| 3 | | |
| 4 | | |
| 3 | |
Exercise price | |
| 25.31 | | |
| 17.76 | | |
| 25.31 | | |
| 17.76 | | |
| 13.82 | |
Stock price | |
| 20.50 | | |
| 17.50 | | |
| 17.50 | | |
| 17.50 | | |
| 13.82 | |
Fair value | |
| 5.94 | | |
| 6.05 | | |
| 4.15 | | |
| 6.90 | | |
| 4.94 | |
| |
Plan
2021 (grant June 8 2022) | | |
Plan
2021 (grant Aug 8 2022) | | |
Plan
2021 (grant Aug 8 2022) | | |
Plan
2021 (grant March 24 2023 | | |
Plan
2021 (grant April 12 2023) | |
Return Dividend | |
| 0 | % | |
| 0 | % | |
| 0 | % | |
| 0 | % | |
| 0 | % |
Expected volatility | |
| 52.60 | % | |
| 53.71 | % | |
| 53.97 | % | |
| 52.00 | % | |
| 52.00 | % |
Risk-free interest rate | |
| 1.60 | % | |
| 1.39 | % | |
| 1.45 | % | |
| 3.20 | % | |
| 3.24 | % |
Expected life | |
| 3 | | |
| 3 | | |
| 4 | | |
| 3 | | |
| 3 | |
Exercise price | |
| 12.95 | | |
| 9.66 | | |
| 9.66 | | |
| 5.42 | | |
| 6.36 | |
Stock price | |
| 13.34 | | |
| 9.75 | | |
| 9.75 | | |
| 6.70 | | |
| 7.08 | |
Fair value | |
| 5.21 | | |
| 3.79 | | |
| 4.32 | | |
| 3.09 | | |
| 3.04 | |
| |
Plan
2021 (grant June 14 2023) | | |
Plan
2022 (grant June 14 2023) | |
Return Dividend | |
| 0 | % | |
| 0 | % |
Expected volatility | |
| 51.28 | % | |
| 51.28 | % |
Risk-free interest rate | |
| 3.36 | % | |
| 3.36 | % |
Expected life | |
| 3 | | |
| 3 | |
Exercise price | |
| 7.19 | | |
| 7.19 | |
Stock price | |
| 7.10 | | |
| 7.10 | |
Fair value | |
| 2.75 | | |
| 2.75 | |
On
March 24, 2023, the Company reduced the exercise price of 75% of the warrants previously granted to warrant holders under
the 2021 Warrants Plan to 5.42 EUR to reflect the decrease in the company’s share price. For the remaining 25% of the warrants
previously granted under the 2021 Warrants Plan, the exercise price will remain unchanged. All other terms and conditions of the re-priced
warrants remain unchanged to the original option agreement. The Company determined the fair value of the options at the date of the modification
(March 24, 2023). The incremental fair value of the re-priced warrants will be recognised as an expense over the period from the
modification date to the end of the vesting period. For the warrants already vested at the date of modification, the incremental fair
value is fully recognised as an expense at date of modification.
The
fair value of the modified warrants was determined using the same models and principles as described above, with the following
model inputs:
| |
Plan 2021
(grant Sept 17 2021) | | |
Plan 2021
(grant Oct 27 2021) | | |
Plan 2021
(grant Feb 21 2022) | | |
Plan 2021
(grant Feb 21 2022) | |
Return Dividend | |
| 0 | % | |
| 0 | % | |
| 0 | % | |
| 0 | % |
Expected volatility | |
| 52.00 | % | |
| 52.00 | % | |
| 52.00 | % | |
| 52.00 | % |
Risk-free interest rate | |
| 3.25 | % | |
| 3.25 | % | |
| 3.17 | % | |
| 3.36 | % |
Expected life | |
| 2 | | |
| 2 | | |
| 2 | | |
| 2 | |
Exercise price | |
| 5.42 | | |
| 5.42 | | |
| 5.42 | | |
| 5.42 | |
Stock price | |
| 6.68 | | |
| 6.68 | | |
| 6.68 | | |
| 6.68 | |
Fair value | |
| 2.48 | | |
| 2.52 | | |
| 2.67 | | |
| 2.49 | |
Incremental Fair value | |
| 2.38 | | |
| 2.40 | | |
| 2.23 | | |
| 2.38 | |
| |
Plan
2021 (grant Feb 21 2022) | | |
Plan
2021 (grant May 14 2022) | | |
Plan
2021 (grant Aug 8 2022) | | |
Plan
2021 (grant Aug 8 2022) | |
Return Dividend | |
| 0 | % | |
| 0 | % | |
| 0 | % | |
| 0 | % |
Expected volatility | |
| 52.00 | % | |
| 52.00 | % | |
| 52.00 | % | |
| 52.00 | % |
Risk-free interest rate | |
| 3.03 | % | |
| 3.13 | % | |
| 3.13 | % | |
| 2.98 | % |
Expected life | |
| 3 | | |
| 2 | | |
| 3 | | |
| 4 | |
Exercise price | |
| 5.42 | | |
| 5.42 | | |
| 5.42 | | |
| 5.42 | |
Stock price | |
| 6.68 | | |
| 6.68 | | |
| 6.68 | | |
| 6.68 | |
Fair value | |
| 3.05 | | |
| 2.75 | | |
| 2.87 | | |
| 3.21 | |
Incremental Fair value | |
| 2.23 | | |
| 1.92 | | |
| 1.28 | | |
| 1.19 | |
The
Company has recognized €2.3 million share-based payment expense for the nine months ended September 30, 2023 (2022: €2.1 million)
of which €0.8 million is related to the incremental fair value of the re-priced warrants.
18. Financial Debt
Financial debt consists of recoverable cash advances
and other loans. Related amounts can be summarized as follows:
| |
As at | |
(in EUR 000) | |
September 30,
2023 | | |
December 31,
2022 | |
Recoverable cash advances - Non-current | |
| 8
407 | | |
| 8
126 | |
Recoverable cash advances
- Current | |
| 685 | | |
| 305 | |
Total Recoverable cash advances | |
| 9
092 | | |
| 8
431 | |
Other loan - Non-current | |
| – | | |
| 63 | |
Other loan - Current | |
| 84 | | |
| 83 | |
Total Other loan | |
| 84 | | |
| 146 | |
Non-current | |
| 8
407 | | |
| 8
189 | |
Current | |
| 769 | | |
| 388 | |
Total Financial Debt | |
| 9
176 | | |
| 8
577 | |
Financial debt related to recoverable cash
advances
Recoverable cash advances received
As at September 30, 2023, the details of
recoverable cash advances received can be summarized as follows:
(in EUR 000) | |
Contractual
advances | | |
Advances
received | | |
Amounts
reimbursed | |
Sleep apnea device (6472) | |
| 1
600 | | |
| 1
600 | | |
| 480 | |
First articles (6839) | |
| 2
160 | | |
| 2
160 | | |
| 494 | |
Clinical trial (6840) | |
| 2
400 | | |
| 2
400 | | |
| 210 | |
Activation chip improvements (7388) | |
| 1
467 | | |
| 1
467 | | |
| 44 | |
Total | |
| 7
627 | | |
| 7
627 | | |
| 1
228 | |
Based on expected timing of sales and after discounting,
the financial debt related to the recoverable cash advances is as follows:
| |
As at | |
(in EUR 000) | |
September 30,
2023 | | |
December 31,
2022 | |
Contract 6472 | |
| 1
669 | | |
| 1
571 | |
Contract 6839 | |
| 2
404 | | |
| 2
214 | |
Contract 6840 | |
| 3
019 | | |
| 2
790 | |
Contract 7388 | |
| 2
000 | | |
| 1
856 | |
Total recoverable cash advances | |
| 9
092 | | |
| 8
431 | |
Non-current | |
| 8
407 | | |
| 8
126 | |
Current | |
| 685 | | |
| 305 | |
Total recoverable cash advances | |
| 9
092 | | |
| 8
431 | |
The amounts recorded under “Current”
caption correspond to the sales-independent amounts (fixed repayment) and sales-dependent reimbursements (variable repayment) estimated
to be repaid to the Walloon Region in the next 12-month period. The estimated sales-independent (fixed repayment) as well as sales-dependent
reimbursements (variable repayment) beyond 12 months are recorded under “Non-current” liabilities.
Changes in the recoverable cash advances can
be summarized as follows:
(in EUR 000) | |
2023 | | |
2022 | |
As at January 1 | |
| 8
431 | | |
| 8
127 | |
Advances reimbursed (excluding interests) | |
| – | | |
| (220 | ) |
Advances payable | |
| (108 | ) | |
| – | |
Initial measurement and re-measurement | |
| 25 | | |
| (77 | ) |
Discounting impact | |
| 744 | | |
| 694 | |
As at September 30 | |
| 9
092 | | |
| 8
524 | |
During
the nine months ended September 30, 2023, the Company received a payment invitation for €108,000 from the Walloon Region which
was not yet paid per as at September 30, 2023 . During the nine months ended September 30, 2022, the Company made €220,000
reimbursements. The Company did not receive any new amounts during the nine months ended September 30, 2023.
19. Trade payables
| |
| As
at | |
(in
EUR 000) | |
| September 30,
2023 | | |
| December 31,
2022 | |
Payables | |
| 2
148 | | |
| 1
873 | |
Invoices to be received | |
| 2
332 | | |
| 3
112 | |
Total Trade payables | |
| 4
480 | | |
| 4
985 | |
The decrease in total trade payables of €0.5 million
as at September 30, 2023 is due to a decrease in invoices to be received of €0.8 million which is compensated by the increase
in trade payables of €275,000.
20. Income taxes and deferred taxes
| |
For
the three months ended September 30 | | |
For
the nine months ended September 30 | |
(in EUR 000) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Current tax income/(expense) | |
| 2
236 | | |
| (944 | ) | |
| 1
121 | | |
| (2
579) | |
Deferred tax income/(expense) | |
| (7 | ) | |
| 879 | | |
| (2 | ) | |
| 2
200 | |
Total Income Tax Income/(Expense) | |
| 2
229 | | |
| (65 | ) | |
| 1
119 | | |
| (379 | ) |
As of January 1, 2022, new tax regulations
are in place in the US in which R&D expenses could no longer be deducted when incurred but instead they should be capitalized only
for tax purposes and amortized over a 5 year period. A current tax liability as well as a deferred tax asset were recognized. This deferred
tax asset was reversed as per December 31, 2022. During the three months ended September 30, 2023, the Company finalized its
R&D tax credit study and reached the conclusion that R&D expenses can be deducted when incurred. The R&D tax credit study
concluded that taking into account that the research and development by the US subsidiary was done under the direction of the parent
in Belgium and benefited Belgian parent’ business, the expenditures in the US should be deducted when incurred. As a result the
current tax liability amounting to €2.2 million was reversed during the three months ended September 30, 2023.
The current tax liability of €2.4 million
includes a liability for uncertain tax positions for an amount of €2.3 million and an income tax liability for an amount of €56,000.
The uncertain tax position was recorded following certain public rulings and guidance issued by tax authorities in one of the jurisdictions
that the Company operates in. For the nine months ended September 30, 2023, an additional accrual of the liability for uncertain
tax positions was recorded for an amount of €363,000 (2022: €69,000).
21. Other payables
| |
As at | |
(in EUR 000) | |
September 30,
2023 | | |
December 31,
2022 | |
Holiday pay accrual | |
| 692 | | |
| 612 | |
Salary | |
| 1
845 | | |
| 2
186 | |
Accrued expenses | |
| 2
274 | | |
| 2
228 | |
Foreign currency option - current | |
| 1
013 | | |
| 10 | |
Other | |
| 228 | | |
| 131 | |
Total other payables | |
| 6
052 | | |
| 5
167 | |
The
increase of €0.9 million in other payables as at September 30, 2023, compared to December 31, 2022, is the result
of an increase of €1 million in the fair value of the foreign currency option and an increase in holiday pay accrual of €80,000
partly offset by a decrease of €0.3 million in salary payables.
22. Derivatives
The Company is exposed to currency risk primarily
due to the expected future USD, AUD and NIS expenses that will be incurred as part of the ongoing and planned marketing, clinical trials
and other related expenses. A financial risk management policy has been approved to i) generate yields on liquidity and ii) reduce the
exposure to currency fluctuations with a timeline up to 24 months and by means of foreign currency swaps.
The
Company has entered into several foreign currency swaps and foreign currency forwards for which the notional amounts are detailed
in the table below:
| |
As at | |
(in EUR 000) | |
September 30,
2023 | | |
December 31,
2022 | |
Foreign currency swaps EUR - NIS (in EUR) | |
| 3
877 | | |
| 542 | |
Foreign currency swaps EUR - NIS (in NIS) | |
| 15
500 | | |
| 2
000 | |
Foreign currency forwards EUR - NIS (in EUR) | |
| 249 | | |
| – | |
Foreign currency forwards EUR - NIS (in NIS) | |
| 1
000 | | |
| – | |
Foreign currency swaps EUR - AUD (in EUR) | |
| 92 | | |
| 379 | |
Foreign currency swaps EUR - AUD (in AUD) | |
| 150 | | |
| 600 | |
Foreign currency swaps USD - EUR (in USD) | |
| 24
393 | | |
| – | |
Foreign currency swaps USD - EUR (in EUR) | |
| 22
000 | | |
| – | |
The following table shows the carrying amount
of derivative financial instruments measured at fair value in the statement of the financial position including their levels in the fair
value hierarchy:
| |
As at
September 30, 2023 | |
(in EUR 000) | |
Level I | | |
Level II | | |
Level III | | |
Total | |
Financial assets | |
| | | |
| | | |
| | | |
| | |
Foreign currency swaps | |
| – | | |
| 21 | | |
| – | | |
| 21 | |
Financial liabilities | |
| | | |
| | | |
| | | |
| | |
Foreign currency swaps | |
| – | | |
| 1
011 | | |
| – | | |
| 1
011 | |
Foreign currency forwards | |
| – | | |
| 2 | | |
| – | | |
| 2 | |
The
fair value is determined by the financial institution and is based on foreign currency swaps rates, foreign currency forward rates
and the maturity of the instrument. All foreign currency swaps and forwards are classified as current as their maturity date is within
the next twelve months.
The change in the balance of the financial assets
is detailed as follows:
(in EUR 000) | |
2023 | | |
2022 | |
Financial asset | |
| | | |
| | |
| |
| | | |
| | |
Opening value at January 1 | |
| 1 | | |
| – | |
Fair value adjustments | |
| 20 | | |
| 66 | |
Closing value at September 30 | |
| 21 | | |
| 66 | |
The change in the balance of the financial liabilities
is detailed as follows:
(in EUR 000) | |
2023 | | |
2022 | |
Financial liability | |
| | | |
| | |
| |
| | | |
| | |
Opening value at January 1 | |
| 10 | | |
| 654 | |
Fair value adjustments | |
| 1
003 | | |
| 2
558 | |
Exchange rate difference | |
| – | | |
| (80 | ) |
Closing value at September 30 | |
| 1
013 | | |
| 3
132 | |
23. Results of operation
Revenue and cost of goods sold
In the nine months ended September 30, 2023,
the Company generated revenue for the amount of €2.5 million (2022: €1.8 million). In the three months ended September 30,
2023, the Company generated revenue for the amount of €1.0 million (2022: €182,000).
Revenue is recognized at a point in time upon
satisfaction of the performance obligation, being the moment control over the Genio® system is transferred to the customer,
which is in general at delivery at customer site or a predefined location in the country of the customer. For certain customers, control
may be transferred upon shipment to the customer in case the incoterms are Ex-Works. The revenue from the Genio® system
consists of a kit of products delivered at the same point in time, and as such revenue does not need to be allocated over the different
products. The revenue is then recognized at an amount that reflects the consideration to which the Company expects to be entitled in
exchange of the Genio® system. In determining the transaction price for the sale of the Genio® system,
the Company considers the effects of variable consideration.
For
the nine month period ended September 30, 2023 the sales (based on country of customer) were generated in Germany (€2.1 million),
Switzerland (€324,000), Austria (€102,000) and Spain (€12,000) (2022: Germany: €1.6 million, Switzerland : €167,000
and Finland: €40,000). For the nine month period ended September 30, 2023, the Company has one customer with individual sales
larger than 10% of the total revenue (2022: two customers).
For the three month period ended September 30,
2023 the sales (based on country of customer) were generated in Germany (€0.7 million), Switzerland (€207,000), Austria
(€20,000) and Spain (€12,000) (2022: Germany: €15,000 and Switzerland: €167,000 ).
Cost of goods sold for the three and nine months
ended September 30, 2023 and 2022:
| |
For
the three months ended September 30 | | |
For
the nine months ended September 30 | |
(in EUR 000) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Purchases of goods and services | |
| 898 | | |
| 151 | | |
| 1
757 | | |
| 933 | |
Inventory movement | |
| (562 | ) | |
| (88 | ) | |
| (827 | ) | |
| (248 | ) |
Total cost of goods sold | |
| 336 | | |
| 63 | | |
| 930 | | |
| 685 | |
Operating expenses
The tables below detail the operating expenses
for the nine months ended September 30, 2023 and 2022:
(in EUR 000) | |
Total cost | | |
Capitalized | | |
Operating
expense for the period | |
Research and development | |
| 26
302 | | |
| (6
972) | | |
| 19
330 | |
Selling, general and administrative expenses | |
| 16
794 | | |
| – | | |
| 16
794 | |
Other income and expenses | |
| (769 | ) | |
| 504 | | |
| (265 | ) |
For the nine months ended September 30, 2023 | |
| 42
327 | | |
| (6
468) | | |
| 35
859 | |
(in EUR 000) | |
Total
cost | | |
Capitalized | | |
Operating
expense for the period | |
Research and development | |
| 23
177 | | |
| (11
891) | | |
| 11
286 | |
Selling, general and administrative expenses | |
| 13
492 | | |
| – | | |
| 13
492 | |
Other income and expenses | |
| (354 | ) | |
| 117 | | |
| (237 | ) |
For the nine months ended September 30, 2022 | |
| 36
315 | | |
| (11
774) | | |
| 24
541 | |
The tables below detail the operating expenses
for the three months ended September 30, 2023 and 2022:
(in EUR 000) | |
Total
cost | | |
Capitalized | | |
Operating
expense for the period | |
Research and development | |
| 8
539 | | |
| (1
971) | | |
| 6
568 | |
Selling, general and administrative expenses | |
| 5
058 | | |
| – | | |
| 5
058 | |
Other income and expenses | |
| (496 | ) | |
| 496 | | |
| – | |
For the three months ended September 30, 2023 | |
| 13
101 | | |
| (1
475) | | |
| 11
626 | |
(in EUR 000) | |
Total
cost | | |
Capitalized | | |
Operating
expense for the period | |
Research and development | |
| 8
360 | | |
| (4
139) | | |
| 4
221 | |
Selling, general and administrative expenses | |
| 4
763 | | |
| – | | |
| 4
763 | |
Other income and expenses | |
| (102 | ) | |
| 15 | | |
| (87 | ) |
For the three months ended September 30, 2022 | |
| 13
021 | | |
| (4
124) | | |
| 8
897 | |
Research and Development expenses
| |
For
the three months ended September 30 | | |
For
the nine months ended September 30 | |
(in EUR 000) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Staff costs | |
| 3
255 | | |
| 2
592 | | |
| 10
636 | | |
| 7
682 | |
Consulting and contractors' fees | |
| 592 | | |
| 802 | | |
| 2
286 | | |
| 2
107 | |
Q&A regulatory | |
| 51 | | |
| 77 | | |
| 196 | | |
| 203 | |
IP costs | |
| 144 | | |
| 131 | | |
| 385 | | |
| 353 | |
Depreciation and amortization expense | |
| 264 | | |
| 320 | | |
| 895 | | |
| 816 | |
Travel | |
| 325 | | |
| 327 | | |
| 896 | | |
| 655 | |
Manufacturing and outsourced development | |
| 2
039 | | |
| 1
424 | | |
| 5
165 | | |
| 3
765 | |
Clinical studies | |
| 1
263 | | |
| 2
325 | | |
| 3
829 | | |
| 6
577 | |
Other expenses | |
| 303 | | |
| 362 | | |
| 1
029 | | |
| 1
017 | |
IT | |
| 303 | | |
| – | | |
| 985 | | |
| 2 | |
Capitalized costs | |
| (1
971 | ) | |
| (4
139 | ) | |
| (6
972 | ) | |
| (11
891 | ) |
Total research and development expenses | |
| 6
568 | | |
| 4
221 | | |
| 19
330 | | |
| 11
286 | |
Before capitalization of €7.0 million
for the nine months ended September 30, 2023 and €11.9 million for the nine months ended September 30, 2022, research
and development expenses increased by €3.1 million or 13 %, from €23.2 million for the nine months ended September 30,
2022, to €26.3 million for the nine months ended September 30, 2023, due to the combined effect of higher clinical, R&D
activities and manufacturing expenses. This increase is mainly in staff, consulting costs and in manufacturing and outsourced development
to support those activities, this increase was offset by a decrease of €2.7 million in clinical study activities due to Dream
Study.
Before capitalization of €2.0 million
for the three months ended September 30, 2023 and €4.1 million for the three months ended September 30, 2022, research
and development expenses increased by €0.2 million or 2 %, from €8.4 million for the three months ended September 30,
2022, to €8.5 million for the three months ended September 30, 2023, due to the combined effect of higher clinical, R&D
activities and manufacturing expenses. This increase is mainly in staff and consulting costs to support those activities and manufacturing
and outsourced development.
Selling, General and Administrative expenses
| |
For the three months ended September 30 | | |
For the nine months ended September 30 | |
(in EUR 000) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Staff costs | |
| 2 321 | | |
| 2 055 | | |
| 7 123 | | |
| 5 384 | |
Consulting and contractors' fees | |
| 1 277 | | |
| 928 | | |
| 5 133 | | |
| 3 032 | |
Legal fees | |
| 117 | | |
| 145 | | |
| 603 | | |
| 560 | |
Rent | |
| 74 | | |
| 245 | | |
| 269 | | |
| 447 | |
Depreciation and amortization expense | |
| 254 | | |
| 179 | | |
| 737 | | |
| 619 | |
IT | |
| 368 | | |
| 109 | | |
| 856 | | |
| 361 | |
Travel | |
| 247 | | |
| 367 | | |
| 677 | | |
| 914 | |
Insurance fees | |
| 274 | | |
| 404 | | |
| 850 | | |
| 1 239 | |
Other | |
| 126 | | |
| 331 | | |
| 546 | | |
| 936 | |
Total selling, general and administrative expenses | |
| 5 058 | | |
| 4 763 | | |
| 16 794 | | |
| 13 492 | |
Selling, general and administrative expenses
increased by €3.3 million or 24 % from €13.5 million for the nine months ended September 30, 2022 to €16.8 million
for the nine months ended September 30, 2023, mainly due to an increase of costs to support the commercialization of Genio®
system in Europe, scale up of the Company and also due to a start of new ERP system implementation.
Selling, general and administrative expenses
increased by €0.3 million or 6 % from €4.8 million for the three months ended September 30, 2022 to €5.1 million
for the three months ended September 30, 2023, mainly due to an increase of costs to support the commercialization of Genio®
system in Europe, scale up of the Company and also due to a start of new ERP system implementation.
Other operating income / (expenses)
| |
For the three months ended September 30 | | |
For the nine months ended September 30 | |
(in EUR 000) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Recoverable cash advances | |
| | | |
| | | |
| | | |
| | |
Initial measurement and re-measurement | |
| (64 | ) | |
| 50 | | |
| (25 | ) | |
| 77 | |
R&D incentives | |
| 556 | | |
| 55 | | |
| 845 | | |
| 192 | |
Capitalization of R&D incentive | |
| (496 | ) | |
| (15 | ) | |
| (504 | ) | |
| (117 | ) |
Other income/(expenses) | |
| 4 | | |
| (3 | ) | |
| (51 | ) | |
| 85 | |
Total Other Operating Income/(Expenses) | |
| – | | |
| 87 | | |
| 265 | | |
| 237 | |
The Company had other operating income of €265,000
for the nine months ended September 30, 2023 compared to other operating income of €237,000 for the nine months ended September 30,
2022.
The Company had no operating income/(expenses)
for the three months ended September 30, 2023 compared to other operating income of €87,000 for the three months ended September 30,
2022.
The other operating income contains the R&D
Incentive (Australia) that relates to an incentive to be received on development expenses incurred by the subsidiary in Australia. The
R&D incentive for the period of nine months ended September 30, 2023 includes a correction for 2022.
24. Employee benefits
| |
For the three months ended September 30 | | |
For the nine months ended September 30 | |
(in EUR 000) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Salaries | |
4 193 | | |
3 133 | | |
12 905 | | |
9 221 | |
Social charges | |
| 312 | | |
| 242 | | |
| 966 | | |
| 742 | |
Fringe benefits | |
| 10 | | |
| (33 | ) | |
| 26 | | |
| 44 | |
Defined contribution plan | |
| 72 | | |
| 69 | | |
| 224 | | |
| 205 | |
Holiday pay | |
| 100 | | |
| 162 | | |
| 324 | | |
| 200 | |
Share-based payment | |
| 527 | | |
| 845 | | |
| 2 284 | | |
| 2 137 | |
Other | |
| 362 | | |
| 229 | | |
| 1 030 | | |
| 517 | |
Total employee benefits | |
| 5 576 | | |
| 4 647 | | |
| 17 759 | | |
| 13 066 | |
| |
| For the three months ended September 30 | | |
| For the nine months ended September 30 | |
(in EUR 000) | |
| 2023 | | |
| 2022 | | |
| 2023 | | |
| 2022 | |
Selling, general and administrative expenses | |
| 2 321 | | |
| 2 055 | | |
| 7 123 | | |
| 5 384 | |
Research & Development expenses | |
| 3 255 | | |
| 2 592 | | |
| 10 636 | | |
| 7 682 | |
Total employee benefits | |
| 5 576 | | |
| 4 647 | | |
| 17 759 | | |
| 13 066 | |
25. Financial income
| |
For the three months ended September 30 | | |
For the nine months ended September 30 | |
(in EUR 000) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Interests | |
| 831 | | |
| 79 | | |
| 1 815 | | |
| 192 | |
Exchange differences | |
| 1 322 | | |
| 4 955 | | |
| 1 752 | | |
| 11 045 | |
Other | |
| 25 | | |
| 93 | | |
| 25 | | |
| 135 | |
Total financial income | |
| 2 178 | | |
| 5 127 | | |
| 3 592 | | |
| 11 372 | |
For the nine month period ended September 30,
2023, the total interest income amounted to €1.8 million (three month period ended September 30, 2023: €0.8 million).
This interest income relates to the term accounts.
For the nine month period ended September 30,
2023, exchange gains amount to €1.8 million (three month period ended September 30, 2023: €1.3 million). For
the year ended December 31, 2022, the closing rate of EUR/USD amounted to 1.07265, while as at September 30, 2023, the rate
of EUR/USD decreased to 1.05803, resulting in unrealized exchange gains on the USD balances.
For the nine month period ended September 30,
2022, exchange gains amount €11.0 million (three month period ended September 30, 2022: €5.0 million), mainly
due to the revaluation of both the Company’s USD cash balance and USD financial assets (note 15). This was related to a decrease
in the rate of EUR/USD compared to December 31, 2021.
For
the nine month period ended September 30, 2022, other financial income mainly to consists of premiums received on foreign
currency options. No premium were received in 2023.
26. Financial expense
| |
For the three months ended September 30 | | |
For the nine months ended September 30 | |
(in EUR 000) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Fair value adjustment | |
| 587 | | |
| 609 | | |
| 1 003 | | |
| 2 558 | |
Recoverable cash advances, Accretion of interest | |
| 248 | | |
| 231 | | |
| 743 | | |
| 694 | |
Interest and bank charges | |
| 34 | | |
| 21 | | |
| 79 | | |
| 124 | |
Interest on lease liabilities | |
| 31 | | |
| 26 | | |
| 91 | | |
| 73 | |
Exchange differences | |
| 133 | | |
| 1 632 | | |
| 848 | | |
| 2 020 | |
Other | |
| – | | |
| 5 | | |
| 1 | | |
| 4 | |
Total Financial expense | |
| 1 033 | | |
| 2 524 | | |
| 2 765 | | |
| 5 473 | |
The fair value adjustment relates to the fair
value adjustment on financial instruments. More information can be found in note 22.
The discounting impact of the recoverable cash
advances is further detailed in note 18 above.
For the nine month period ended September 30,
2023, exchange losses amount to €0.8 million (three month period ended September 30, 2023: €133,000), mainly due
to the revaluation of both the Company’s USD cash balance and USD financial assets (note 15). We refer to note 25 for more details
on the revaluation of both the Company’s USD cash balance and USD financial assets as per September 30, 2023.
The Company holds its USD cash balances and term
deposits as they expect to incur cash-outflows in the US relating to both clinical costs (DREAM and ACCESS) and to the commercial launch
of the Genio® system.
27. Loss Per Share (EPS)
The Basic Earnings Per Share and the Diluted
Earnings Per Share are calculated by dividing earnings for the year by the weighted average number of shares outstanding during the year.
As the Company is incurring net losses, outstanding warrants have no dilutive effect. As such, there is no difference between the Basic
and Diluted EPS.
EPS for September 2023 has been presented
in the income statement taking into account resolutions adopted by the shareholders’ meeting of February 21, 2020. All existing
preferred shares were converted into common shares, and then a share split of 500:1 was approved by the shareholders’ meeting.
| |
| For the three months ended September 30 | | |
| For the nine months ended September 30 | |
| |
| 2023 | | |
| 2022 | | |
| 2023 | | |
| 2022 | |
As at September 30, after conversion and share split | |
| | | |
| | | |
| | | |
| | |
Outstanding common shares at period-end | |
| 28 673 985 | | |
| 25 846 279 | | |
| 28 673 985 | | |
| 25 846 279 | |
Weighted average number of common shares outstanding | |
| 28 667 159 | | |
| 25 836 279 | | |
| 27 729 401 | | |
| 25 809 995 | |
Number of shares resulting of the exercise of outstanding warrants | |
| 2 384 250 | | |
| 1 916 125 | | |
| 2 384 250 | | |
| 1 916 125 | |
Basic and Diluted EPS for the three and nine
month period ended September 30, 2023 and 2022 based on weighted average number of shares outstanding after conversion and share
split are as follows:
| |
For the three months ended September 30 | | |
For the nine months ended September 30 | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Loss of year attributable to equity holders (in EUR) | |
(7 612 000 | ) | |
(6 240 000 | ) | |
(32 319 000 | ) | |
(17 929 000 | ) |
Weighted average number of common shares outstanding (in units) | |
28 667 159 | | |
25 836 279 | | |
27 729 401 | | |
25 809 995 | |
Basic earnings per share in EUR (EUR/unit) | |
| (0.266 | ) | |
| (0.242 | ) | |
| (1.166 | ) | |
| (0.695 | ) |
Diluted earnings per share in EUR (EUR/unit) | |
| (0.266 | ) | |
| (0.242 | ) | |
| (1.166 | ) | |
| (0.695 | ) |
28. Other commitments
The Company has granted in 2022 an amount of
€0.5 million for educational grant starting on January 1, 2023 until December 31, 2024. The first installment of
€250,000 is paid in January 2023, the second installment of €250,000 is due in January 2024.
29. Related Party Transactions
Transactions between the Company and its subsidiaries
have been eliminated in consolidation and are not disclosed in the notes. Related party transactions are disclosed below.
Remuneration of Key Management
The
remuneration of the senior management consists of the remuneration of the CEO of the Company for the three and nine months ended
September 30:
| |
For the three months ended September 30 | | |
For the nine months ended September 30 | |
(in EUR 000) | |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Short-term remuneration & compensation | |
| 260 | | |
| 120 | | |
| 656 | | |
| 391 | |
Share based payment | |
| 33 | | |
| 47 | | |
| 134 | | |
| 102 | |
Total | |
| 293 | | |
| 167 | | |
| 790 | | |
| 493 | |
Transactions with Non-Executive Directors and Shareholders:
| |
For the nine months ended September 30, 2023 | | |
For the nine months ended September 30, 2022 | |
(in EUR 000) | |
R&D Collaboration | | |
Consulting services | | |
Board Remuneration | | |
R&D Collaboration | | |
Consulting services | | |
Board Remuneration | |
Cochlear | |
| 182 | | |
| – | | |
| – | | |
| 1 749 | | |
| – | | |
| – | |
MINV SA | |
| – | | |
| – | | |
| – | | |
| – | | |
| 60 | | |
| – | |
Ray Cohen | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| 20 | |
Donald Deyo | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| 21 | |
Robert Taub | |
| – | | |
| – | | |
| 97 | | |
| – | | |
| – | | |
| 61 | |
Kevin Rakin | |
| – | | |
| – | | |
| 47 | | |
| – | | |
| – | | |
| 33 | |
Pierre Gianello | |
| – | | |
| – | | |
| 51 | | |
| – | | |
| – | | |
| 36 | |
Jan Janssen | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| 24 | |
Jurgen Hambrecht | |
| – | | |
| – | | |
| 44 | | |
| – | | |
| – | | |
| 38 | |
Rita Mills | |
| – | | |
| – | | |
| 49 | | |
| – | | |
| – | | |
| 28 | |
Giny Kirby | |
| – | | |
| – | | |
| 47 | | |
| – | | |
| – | | |
| 15 | |
Wildman Ventures LLC | |
| – | | |
| – | | |
| 56 | | |
| – | | |
| – | | |
| – | |
Total | |
| 182 | | |
| – | | |
| 391 | | |
| 1 749 | | |
| 60 | | |
| 276 | |
Amounts outstanding at period-end | |
| – | | |
| – | | |
| 110 | | |
| 970 | | |
| 60 | | |
| 126 | |
| |
For the three months ended September 30, 2023 | | |
For the three months ended September 30, 2022 | |
(in EUR 000) | |
R&D Collaboration | | |
Consulting services | | |
Board Remuneration | | |
R&D Collaboration | | |
Consulting services | | |
Board Remuneration | |
Cochlear | |
| – | | |
| – | | |
| – | | |
| 413 | | |
| – | | |
| – | |
Ray Cohen | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| 16 | |
Donald Deyo | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| 7 | |
Robert Taub | |
| – | | |
| – | | |
| 31 | | |
| – | | |
| – | | |
| 19 | |
Kevin Rakin | |
| – | | |
| – | | |
| 15 | | |
| – | | |
| – | | |
| 8 | |
Pierre Gianello | |
| – | | |
| – | | |
| 19 | | |
| – | | |
| – | | |
| 1 | |
Jan Janssen | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| 5 | |
Jurgen Hambrecht | |
| – | | |
| – | | |
| 15 | | |
| – | | |
| – | | |
| 14 | |
Rita Mills | |
| – | | |
| – | | |
| 15 | | |
| – | | |
| – | | |
| 5 | |
Giny Kirby | |
| – | | |
| – | | |
| 13 | | |
| – | | |
| – | | |
| 12 | |
Wildman Ventures LLC | |
| – | | |
| – | | |
| 16 | | |
| – | | |
| – | | |
| – | |
Total | |
| – | | |
| – | | |
| 124 | | |
| 413 | | |
| – | | |
| 87 | |
Amounts outstanding at period-end | |
| – | | |
| – | | |
| 110 | | |
| 970 | | |
| 60 | | |
| 126 | |
The Company and Cochlear Limited, or Cochlear,
have entered into a collaboration agreement, dated November 2018, under which they agreed to collaborate to further develop and
progress commercialization of implantable treatments for sleep disordered breathing conditions. A new Statement of Work was entered into
on June 8, 2020. Under this agreement, Cochlear is working with the Company in developing and enhancing the next generation implantable
stimulator. This collaboration agreement led to a financial impact of €182,000 and €1.7 million for the nine months ended
September 30, 2023 and 2022 respectively. In April 2023, the project came to its end after development milestones were reached.
On September 28, 2023, the Company announced a partnership with ResMed in Germany to increase OSA awareness and therapy penetration in
the German market. The Company and ResMed Germany will establish a continuum of care that will educate and guide OSA patients in the German
market from diagnosis through treatment. Together, the companies will work to accelerate patient identification and better support patient
set-up on the appropriate therapy.
30. Events after the Balance-Sheet Date
The Company confirms that despite the conflict
between Israel and Hamas, operations are continuing notably regarding R&D and production with no major impact and the assets are
currently safeguarded. The Company is not suffering impact of this conflict.
Responsibility
statement
We certify that, to the best of our knowledge,
a) | the condensed consolidated interim financial
statement, prepared in accordance with the applicable standards for financial statements,
give a true and fair view of the assets, liabilities, financial position and results of the
Company and the undertakings included in the consolidation taken as a whole; and |
b) | this interim management report provides a true
and fair overview of the development, results and the position of the Company and the undertakings
included in the consolidation taken as a whole, as well as a description of the principal
risks and uncertainties that they face. |
Mont-Saint-Guibert, November 8, 2023.
On behalf of the board of directors
Robert Taub, Chairman |
Olivier Taelman, CEO |
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